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| 50TH ANNUAL CONFERENCE OF IPSCON-2017 |
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| Year : 2021 | Volume
: 53
| Issue : 7 | Page : 192-387 |
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50th Annual Conference of IPSCON-2017
| Date of Web Publication | 29-Dec-2021 |
Correspondence Address:
 Source of Support: None, Conflict of Interest: None  | Check |
How to cite this article:
. 50th Annual Conference of IPSCON-2017. Indian J Pharmacol 2021;53, Suppl S1:192-387 |
| » Prize Presentations ACHARI PRIZE | |  |
| » ACH-1: Ivermectin Saga: From Killing Worms to Combatting Metabolic Syndrome | | |
Vyas Navdha, Gandhi Tejal, Shah Hital
Department of Pharmacology, Anand Pharmacy College, Anand, Gujarat, India
E-mail: [email protected]
The increasing prevalence trends in the epidemic of metabolic Syndrome worldwide represents a matter of immense healthcare concern. The metabolic syndrome so called “deadly quartet” is an insulin resistant state that is characterized by cluster of cardiovascular risk factors, including abdominal obesity, hyperglycemia, elevated blood pressure and combined dyslipidemia. Many research studies prove that bile acid regulating receptor farnesoid X receptor (FXR) plays an important role in treating disorder of glucose and lipid homeostasis. In silico screening, docking calculation and in-vitro experiments have shown that Ivermectin functions as FXR ligand. This study aimed to interpret the effect of Ivermectin on metabolic syndrome. Male Sprague- dawley rats (model control) were fed high fat high carbohydrate (HFHC) diet for 90 days and olanzapine (15 mg/kg i.p.) was given weekly for the span of 28 days for inducing metabolic syndrome in rats whereas normal control was fed with standard chow diet and R.O. water. Treatment group were given Ivermectin (0.6 mg/kg) orally administered along with HFHC diet (90 days) and olanzapine (15 mg/kg) for the duration of 28 days. Model control developed the signs of metabolic syndrome including elevated abdominal and hepatic fat deposition, impaired glucose tolerance, hypertension, altered lipid profile (TG, TC, LDL, HDL, VLDL), Liver profile (ALT, AST and ALP) and increased oxidative stress. The treatment with ivermectin presented promising results in analysis of left ventricular dysfunction (LVEDP, dp/dtmax., dp/dtmin). Moreover, treatment group suggests that Ivermectin prevented elevation in blood pressure,
oxidative stress and ameliorated lipid profile (TG, TC, LDL, HDL, VLDL), liver profile (ALT, AST and ALP) and glucose level suggesting the protective effect of ivermectin in maintenance of lipid, liver enzyme and glucose levels. Furthermore, results of histopathological studies (liver and heart sample) also supports our results which indicates that ivermectin may be a promising candidate for therapies combatting metabolic syndrome.
Keywords: Farnesoid X receptor, high fat high carbohydrate diet, ivermectin, metabolic syndrome, olanzapine
| » ACH-2: Effect of Montelukast in Experimental Model of Parkinson's disease | | |
Nagarajan V, Marathe PA
Department of Pharmacology and Therapeutics, Seth GS Medical College and Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objectives: Despite the availability of many drugs offering symptomatic relief in Parkinson's disease, there are no drugs available offering neuroprotective effect. Hence, it was decided to evaluate the neuroprotective effect of montelukast, an anti-inflammatory drug, in rotenone induced model of Parkinson's disease in rats. Methods: 48 male wistar rats were randomly divided into three groups. Group 1: Vehicle control, Group 2: Montelukast 5mg/kg, Group 3: Montelukast 10mg/kg. All the groups received rotenone 2.5mg/kg for 10 days. On day 25, 24 hours after 14 days of study drug administration, the rats were subjected to open field test, rota rod test and catalepsy test. Brain samples of animals from each group were collected for Malondialdehyde (MDA), Glutathione (GSH) and TNFα analysis. Results: In the open field test both the doses of montelukast showed significant increase in the locomotor activity and significant decrease in the immobility time compared to vehicle (p<0.05). In rotarod test, montelukast 5mg/kg and 10mg/kg showed significant increase in the time to fall, compared to vehicle (p<0.05). In catalepsy test, both doses of montelukast showed significant decrease in the retraction time compared to vehicle (p<0.05). Montelukast, both doses, significantly decreased the MDA levels compared to vehicle and significantly increased the GSH levels (p<0.05). Both the groups of montelukast 5mg/kg 10mg/kg showed significant decrease in the TNFα levels compared to vehicle. (p<0.01). Conclusions: Montelukast showed potential neuroprotective effect by virtue of its anti-oxidant and anti-inflammatory actions.
Keywords: Leukotrienes, montelukast, neuroprotection, TNFα
| » ACH-3: Critical Appraisal of Published Research Papers - A Reinforcing Tool for Research Methodology: Questionnaire Based Study | | |
Khatri N, Gajbhiye S, Tripathi R, Parmar U
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objectives: Critical appraisal of published research papers is routinely conducted in pharmacology departments of medical colleges across Maharashtra as a journal club activity and this forms an important part of their post graduation curriculum. During this activity postgraduate (PG) students review original research papers and pick up strengths and flaws in the paper from research methodology perspective. The objective of this study was to evaluate the perception of pharmacology PG students and PG teachers towards use of critical appraisal as a reinforcing tool for research methodology. Evaluation of performance of in-house pharmacology PG students in the critical appraisal activity constituted secondary objective of the study. Materials and Methods: The study was conducted in two parts. In Part I of the study, a cross-sectional questionnaire based evaluation on perception towards critical appraisal activity was carried out in pharmacology PG students and PG teachers. In part II of the study, journal club score sheets of 2nd and 3rd year pharmacology students at Seth GS Medical College over the past 4 years were evaluated to gauge the performance of in-house pharmacology students in this activity. Results: 127 PG students and 32 PG teachers participated in this study. More than 50 % of students and teachers agreed to all items of the questionnaire and acknowledged the importance of critical appraisal in research planning and conduct. Journal club score sheet assessments suggested that there was no statistically significant difference in critical appraisal skills of 2nd (n=44) and 3rd year (n=32) pharmacology students. Conclusion: Journal article criticism is an important educational activity for pharmacology PG students and is considered as an important tool to develop a good research attitude among them.
Keywords: Journal club, Maharashtra, perception, performance, pharmacology
| » ACH-4: Experimental Study to Evaluate the Effect of Piclamilast on Animal Models of Spatial and Emotional Memory | | |
Bedrekar MS, Kurle DG, Raut SB, Marathe PA
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Maharashtra University of Health and Sciences, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objective: None of the currently available treatment for dementia halts the progression of the disease. Therefore we conducted this study with the objective of evaluating memory enhancing effect of phosphodiesterase enzyme inhibitor 4, piclamilast in animal models of dementia. Materials and Methods: 24 mice & 48 rats were divided into four groups (n=6/group): vehicle control (normal saline), disease control (scopolamine), and positive control (rivastigmine), study group (piclamilast). Normal saline, piclamilast, and rivastigmine were given intraperitoneally for 15 consecutive days. Scopolamine was given as an amnestic agent. Two chambered box model was used for emotional memory. For spatial memory, elevated plus maze & Morris water maze models were used. Following Morris water maze, cAMP level of rat brain tissues was measured using cAMP ELISA kit. Results: Piclamilast group improved emotional memory in two-chambered box test (p<0.05). It also improved spatial memory in elevated plus maze test (p<0.05) and Morris water maze test (p<0.05). Results were comparable to positive control, rivastigmine (p>0.05). Piclamilast group significantly increase cAMP levels in rat brain (p<0.05). Conclusion: Piclamilast improves emotional & spatial memory in animal models of dementia by increasing CAMP levels in the brain.
Keywords: cAMP, elevated plus maze, morris water maze, PDE4 inhibitor, rivastigmine
| » ACH-5: Renal Fibrosis is attenuated by Chronic Glucagon and GLP-1 Coagonist Treatment: Role of Activation of FGF21 and Improved Insulin Sensitivity | | |
Brijesh Sutariya, Amit Joharapurkar, Vishal Patel, Samadhan Kshirsagar, Maulik Patel, Hiren Patel, Dheerendra Pandey, Dipam Patel, Ramchandra Ranvir, Shekhar Kadam, Rajesh Bahekar, Mukul Jain
Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India
E-mail: [email protected]
Objective: Fibroblast growth factor 21 (FGF21) levels are increased in patients with chronic kidney disease. Recently, we have observed that a balanced coagonist of glucagon and GLP-1increases FGF21 levels in mice and hamster models of metabolic syndrome. In this study, we investigated the correlation between FGF21 expression and improvement in renal function after the treatment of the coagonist of glucagon and GLP-1 in mouse models of renal fibrosis. Methods: Obese and diabetic C57 db/db mice and adenine-rich diet fed C57 mice were used as the models of renal fibrosis. These mice were treated with the coagonist-Aib2 C24 Chimera2 (150 μg/kg, sc) for twelve weeks. At the end of the treatment, kidney function, histology, markers of fibrosis and inflammation, and plasma biochemistry were assessed. Results: Coagonist treatment in db/db mice induced a significant increase in FGF21 levels, and reduced nephrotoxicity and oxidative stress. This treatment caused a significant decrease in body weight, plasma lipids, and improved glucose tolerance and insulin sensitivity. Biochemical changes in kidney function markers were strongly associated with improvement in renal histology, and also with changes in expression of inflammatory (IL-6, TNF-α, MCP-1) and pro-fibrotic (TGFβ, Collagen and α-SMA) genes. These beneficial changes were attenuated by the co-treatment of an antagonist of FGF21R. In adenine-rich diet fed C57BL6/J mice, coagonist treatment did not improve the renal function and caused only a minor increase in FGF21. Conclusion: Coagonist of GLP-1 and glucagon receptors improves renal fibrosis by improvement in FGF21 signalling caused by phenotypic changes in insulin sensitivity.
Keywords: Coagonist, fibroblast growth factor 21, GLP-1, glucagon, insulin sensitivity, renal fibrosis
| » ACH-6: Ameliorating Effect of Punica granatum on Advanced Glycation End Products Induced Cataractogenesis in Diabetic Rats | | |
Swathi P, Eswar Kumar K
AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India
E-mail: [email protected]
Objective: To evaluate the role of aqueous pericarp extract of Punica granatum (APPG) for antidiabetic activity and its role in inhibition of formation of advanced glycation end products induced cataractogenesis in STZ induced diabetic rats. Materials and Methods: Streptozocotin (50mg/kg., i.p) and nicotinamide (100mg/kg., i.p) was used to induced the diabetes mellitus in Wistar albino rats. The treatment groups receiving the gliclazide (1mg/kg) and APPG (50 and 100mg/kg body weight) once daily for the period of 12 weeks. At the end of every 4 weeks the serum glucose levels were estimated. The protein, SOD, CAT, GSH and aldose reductase were estimated. The anti-inflammatory mediator like TNF α, IL6 and CRP levels were estimated. The protein carbonyl content (PCO) and advanced glycation end products (AGEs) was estimated in serum and lens homogenates. Slit lamp microscope and fundoscope was done to assess the cataract. The retinal sections were studied for histopathological changes. Results: The APPG showed significant reduction in glucose and significant elevation od antioxidant enzymes and non enzymatic antioxidants and reduction of inflammatory mediators, PCO and AGEs in both serum and lens homogenate were found to be reduced with the treatment of APPG in STZ induced diabetic rats. Slit lamp examination, fundoscope and histopathology showed improvement in retinal changes in APPG treated rats compared to diabetic rats. Conclusions: The beneficial role of the APPG in inhibiting the formation of AGEs in the development of diabetic cataractogenesis might be due to the presence like tannins, anthocyanins and polyphenols.
| » ACH-7: Observational Study to Evaluate Prescription Pattern of Analgesics Used in Perioperative Period | | |
Patankar PS, Panchal RD, Joshi SS, Shetty YC, Salgaonkar S
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background: Pain is an unpleasant sensory and emotional experience associated with potential tissue damage. There are limited observational Prescription pattern studies of analgesics in perioperative period in tertiary care hospitals for which this study was carried out in Orthopaedic, General Surgery and Plastic Surgery departments. Objective: The main objective was to study prescription patterns in perioperative period with secondary objective to study specific use of opioids and pain relief. Materials and Methods: 250, 250 and 100 patients were taken from Orthopaedic, General Surgery and Plastic Surgery departments respectively. The analgesics commonly used in pre-operative, intro-operative and post-operative period were observed. The use of opioids in the perioperative period, number of FDCs used, number of generic drug prescription and pain relief post-operatively were also observed. Analysis was done using descriptive statistics. Results: Total analgesics prescribed were 1168, 117 and 369 in Orthopaedic, General Surgery and Plastic Surgery departments respectively and maximum in intra-operative period. Most commonly used analgesic in preoperative and post-operative period was Paracetamol and that in intra-operative period was Fentanyl. NSAIDs were mainly prescribed by General Surgery department in post-operative period. The amount of pain in post-operative period after analgesics was mild as per Visual Analogue Scale (VAS). Conclusion: This study revealed that in preoperative period the most common analgesic used is paracetamol, in intraoperative period; maximum patients received fentanyl and in post-operative paracetamol was most commonly used.
Keywords: Analgesics, perioperative, prescription pattern
| » ACH-8: Effect of NMDA Receptor Antagonism on Memory Reconsolidation in Stress Induced Depression Model in C57BL/6 Mice | | |
Raut SB, Potey AV, Nagarajan VB, Marathe PA
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objectives: Incidence of depression is increasing worldwide without significant advances in treatment in last 20 years. We wanted to find out whether erasure of autobiographical memories using NMDA receptor antagonist can be used to treat depression. Materials and Methods: 24 adult C57BL/6 mice, weighing between 20-25 grams, were used. The study was carried out two parts: In part I, we standardized footshock stress induced model of depression. In this model each animal received 20 footshocks everyday for 15 days for induction of depression. After which they were assessed for depression using forced swim test. In part II, we tested the effect of NMDA receptor antagonist (MK 801) on memory reconsolidation in footshock stress induced depression model. After induction of depression as mentioned in Part I, animals were re-exposed to footshock environment on next day for activation of memory. Drugs were given to prevent reconsolidation of memory. On the following day, animals were again tested for depression using forced swim test. Time of immobility during forced swim test was recorded using video tracking system. Results: In Part I, the immobility time of stressed rats (78±52.10) was significantly more as compared to unstressed rats(18±17.56, P = 0.039) suggesting that the model was standardized. In Part II, the immobility time of animals in MK 801 group (44±40.22) was comparable to control group (47.66±34.56, P = 0.877). Conclusion: MK 801 did not show any antidepressant effect hence we conclude that it did not inhibit memory reconsolidation.
| » ACH-9: A Study to Determine Pharmacogenomic Predictors of Efficacy and Safety of Azathioprine Therapy in Patients with IBD | | |
Phulen Sarma, Gaurav Muktesh1, Shringika Soni, Abhishek Mishra, Rahul Singh1, Ajay Patial2, Ashutosh Singh, Mansi Arora3, Narender Dhaka1, Rakesh Kochhar1, Usha Dutta1, Savita Verma Attri2, Deepak Kaul3, Bikash Medhi
Departments of Pharmacology, 1Gastroenterology, 2Pediatric Biochemistry and 3Experimental Medicine and Biotechnology, PGIMER, Chandigarh, India
Introduction: Inflammatory bowel disease (IBD) is characterized by chronic relapsing remitting inflammation of gut mucosa and subsequent complications of it like ulcerations, stricture etc. Azathioprine is frequently used in the management of inflammatory bowel disease, but associated complications like hepatotoxicity, myelotoxicity, pancreatic toxicity limits its use. TPMT is an important biomarker of azathioprine safety. But the data from Japanese and Chinese population is controversial and don't favor TPMT genotyping in routine clinical use. Till now, no data is there in Indian population. So, in this study, we want to evaluate pharmacogenomic (TPMT genotype) and metabolomics (Intraerythrocytic 6-thioguanine level) parameters as a biomarker of azathioprine safety and efficacy in Indian population. Materials and Methods: The primary objective of the study was evaluation of prevalence of TPMT gene polymorphism in Indian patients with inflammatory bowel disease and effect of TPMT polymorphism on hematological toxicity of azathioprine. Secondary objectives were evaluation of association between TPMT genotype and 6-TGN levels, intra-erythrocyte 6-TGN level with azathioprine toxicity, intra-erythrocyte 6-TGN level and with treatment efficacy. A prospective observational study was carried out in PGIMER, Chandigarh to evaluate the above objactives. The sytudy was initiated after ethical committee approval. Participant was recruited in the study only after obtaining of informed consent and fulfilling inclusion exclusion criteria. Disease activity was measured by using mayo and CDAI score. Toxicity was assessed as per predefined criteria. Clinical data and laboratory parameters were entered in case record form. Genomic data was obtained using real time PCR. Azathioprine metabolite level (6-thioguanine level) was measured by reverse phase HPLC. Statistical analysis was done by SPSS (version 22) software as per data type and distribution. Results: A total of 193 participants were recruited for the study. 13.9% had myelosuppression, 3.48% had hepatoxicity and 1.16% had pancreatotoxicity. Our population data regarding Wild type had a genotype frequency of 93.2% and TPMT*1/3C 6.73%. Allelic frequency of TPMT*1 was 96.63% and TPMT*3C was 3.73%. No significant association was found between TPMT polymorphism and Overall ADR [1.122 (0.273-5.479)], Myelotoxicity [0.870 (0.097-7.776), Hepatotoxicity [0.962 (0.92-1.005), Pancreatitis [0.987 (0.96-1.01)], Digestive intolerance [1.071 (0.238-4.822)], Skin reaction [0.936 (0.88-0.99)], Arthralgia [2.325 (0.502-10.772)], Alopecia [0.987 (0.96-1.01)], headache [2.917 (0.502-16.945)], back pain [0.476 (0.055-4.131)], anxiety [0.97 (0.93-1.01)], insomnia [0.974 (0.94-1.01)], opportunistic infection [0.936 (0.883-0.992)]. 6-TGN level was not significantly different between wild type and TPMT heterozygous individuals. 6-TGN level was significantly higher in patients with myelotocity compared to those without it and patients in remission compared to patients not in remission. A cut of 6-TGN level of 400pmol/8×108 RBC had a 100% specificity and positive predictive value for predicting myelotoxicity. And 6-TGN level >200 pmol/8×108 RBC had a sensitivity of 73.33% and specificity of 73.58% for predicting remission. Conclusion: In our study, we did not find any significant association between TPMT status and adverse drug reaction of azathioprine. 6-TGN was found to be a better biomarker for azathioprine safety and efficacy. The therapeutic range of 6-TGN level for Indian patients ranges from 200-400 pmol/8×108 RBC, which is little low than western values.
| » Gufic Prize | | |
| » GUFIC-1: Evaluation of the Protective Effect of Phyllanthus Emblica against NSAID Induced Enteropathy: An Experimental Study in Rats | | |
Dabba SG, Rege NN
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To evaluate the protective ability of aqueous extract of Phyllanthus emblica against NSAID induced small intestinal damage. Materials and Methods: The animals were randomized into 6 groups (n=18/group). There were 2 diseased animal models. Model 1 wherein diclofenac (6.75 mg/kg twice a day for 9 doses) was administered to rats pretreated with either vehicle, low dose (300 mg/kg) or high dose (600 mg/kg) of Phyllanthus emblica and Model 2 wherein 3 insulting agents viz. diclofenac, low dose aspirin (10 mg/kg/day for 8 days) and omeprazole (10 mg/kg twice a day for 9 days) were given concurrently to rats pretreated with either vehicle, low or high dose of Phyllanthus emblica. The variables assessed were hematocrit, histopathology of small intestine, bacterial translocation, nitric oxide production, myeloperoxidase activity and Barrier mucus content. Results: In both the models, pretreatment with Phyllanthus emblica in a dose of 600mg/kg/day was found to preserve intestinal mucosal structure (p<0.01) and prevent rise in NO and MPO (p< 0.001) and reduction in barrier mucus content and bacterial translocation (p< 0.001) compared to the vehicle control. Protection offered by the low dose Phyllanthus emblica was partial and restricted to MPO, mucus content and bacterial translocation in both the models. Conclusion: Pretreatment with Phyllanthus emblica offered protection in dose dependent manner against enteropathy induced by diclofenac alone as well as combination of NSAIDs and omeprazole; 600mg/kg/day dose significantly prevented the adverse effects of NSAIDs on small intestine.
Keywords: Aspirin, diclofenac, myeloperoxidase, nitric oxide, omeprazole
| » GUFIC-2: A Prospective Randomized Placebo-controlled Double-blind Comparative Pilot Study to Evaluate the Efficacy of Chlorophytum Borivilianum on Physical Performance | | |
Dethe PD, Tripathi RK, Rege NN, Bhojne SK
E-mail: [email protected]
Objectives: To study the adaptogenic effect of Chlorophytum borivilianum (CB) on physical performance when exposed to accustomed (AA) & unaccustomed activity (UA), and effect of CB on heart rate (HR) & blood pressure (BP) in the presence of UA and effect on muscle strength in comparison with placebo. Methods: Placebo-controlled, double blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented participants (n=60) were randomly assigned into 2 groups of study drug (3 gm/day) or placebo (3 gm/day) for 2 months. They were assessed at day 0, 30, 60 with physical stressors [6-minute walk test (6MWT)– distance, HR & BP, 6-minute exercise test (6ETC) - distance, max & average speed, fixed workload test (FWT)– SBP, DBP, HR on cycle ergometer], Jammars' dynamometer test for handgrip strength (HG) test on each visit. Results: In 6MWT in CB group distance on day 30 (456±42.1) & day 60 (468.3±0.4) was significantly increased when compared with day 30 (422.6±45.7) & day 60 (419.6±45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92±0.6 which was significantly more than that of placebo group 2.4±0.6. On day 60 in FWT DBP in CB group was 75.8±4.4 which was significantly low compared to placebo group 82.4±7.4 (p<0.05). Conclusion: CB increased physical performance when exposed to AA when given for short duration and increased performance in UA was seen when it was given for longer duration thus validating its adaptogenic potential.
Keywords: Adaptogenic activity, cycle ergometer, safed musali
| » GUFIC-3: Hepatoprotective Effects of Phyllanthus emblica in a Murine Model of Non-alcoholic Steatohepatitis Induced by Methionine Choline Deficient Diet and Endotoxin | | |
Kanase HR1,2, Rege NN1,2
1Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, 2Maharashtra University of Health Sciences, Nashik, Maharashtra, India
E-mail: [email protected]
Objective: To carry out comparative evaluation of hepatoprotective effects of Phyllanthus emblica (Pe) and silymarin in a murine model of non-alcoholic steatohepatitis (NASH) induced by Methionine Choline Deficient (MCD) diet and endotoxin. Materials and Methods: 40 mice were divided into five groups (n=8/group): Disease control, positive control (silymarin 100 mg/kg/day p.o.), low, medium and high dose of Pe (390, 780, 1560 mg/kg/day p.o.). All these groups along with the respective study drugs were fed with MCD diet ad libitum for 8 weeks followed by i.p. administration of endotoxin (0.5μg/gm body weight of animal). The variables assessed were body weight, liver weight, liver volume, serum transaminases (ALT & AST), hepatic triglyceride and liver histopathology. Results: Disease control group showed signs of steatohepatitis. Concomitant administration of Pe in a dose of 1560mg/kg/day p.o. significantly prevented an increase in liver weight, liver volume, ALT, AST, hepatic triglyceride levels and exhibited low histopathologic score as compared to the Disease control group (p < 0.05). These effects were comparable to that of silymarin (p > 0.05). However, the protection offered by medium and low dose was partial and was restricted to liver weight, liver volume and serum ALT & AST. Conclusion: Pre-treatment with Pe offered protection in dose dependent manner against NASH induced by MCD diet and endotoxin with 1560 mg/kg/day dose showing the best evidence for hepatoprotection, which was comparable to that observed with silymarin.
Keywords: Methionine choline deficient diet, non-alcoholic steatohepatitis, Phyllanthus emblica
| » GUFIC-4: To Evaluate Nephroprotective Effect of Ethanolic Extract of Flaxseed in Gentamicin Induced Nephrotoxicity in Wistar Rats | | |
Bhojne SK, Bhide SS, Dethe PD
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To find out Nephroprotective effect of Ethanolic extract of Flaxseed in Gentamicin induced Nephrotoxicity in Wistar rats. Methods: The study was initiated after animal ethics committee approval in 40 adult male Wistar rats. They were randomly divided into 6 groups with 8 rats in each group except normal control. Group 1: Normal control, Group 2: Disease control, group 3: positive control (αlipoic acid) and Groups 4, 5, and 6 were study group received 0.7, 1.4 and 2.8 mg/kg of ethanolic extract of Linum Usitatissimum (EELU) respectively. All groups, except Group 1, concomitantly received gentamicin 150 mg/kg/day for 10 days. Parameters measured were body weight, blood urea nitrogen (BUN), Serum creatinine, kidney malondialdehyde (MDA), and glutathione (GSH) levels and kidney injury on histopathology. Results: EELU showed a nephroprotective effect at the dose of 2.8 mg/kg/day in Gentamicin-induced AKI in rats at the end of 10 days. EELU in the dose of the 0.7 and 1.4mg/kg/day doses failed to show such effect in terms of Serum Creatinine. While1.4 mg/kg/day dose of EELU showed significant improvement in histopathology and BUN when compared with positive control (P < 0.05). Conclusion: The present study demonstrated the nephroprotective effect at high dose of EELU in the model of gentamicin-induced nephrotoxicity in Wistar rats with an acute kidney injury.
Keywords: Acute kidney injury, ethanolic extract, Linum usitatissimum
| » GUFIC-5: Evaluation of the Protective Effect of Paeonia emodi Wall on Rat Model of Parkinson's Disease Induced by 6 Hydroxy Dopamine | | |
Kamble AP, Jalgaonkar SV, Parmar UI
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To evaluate effect of ethanolic extract of Paeonia emodi Wall (PEW) on neurobehavioral tests (NBTs) in 6- Hydroxy dopamine (6-OHDA) induced Parkinson's disease (PD) in wistar rats in vivo and its anti-oxidant and free radical scavenging property in vitro. Methods: Study was done in 2 phases using wistar rats of either sex weighing from 200-300 grams. In phase 1, PD was induced by intra-striatal (I.S.) injection of 6 – OHDA in disease control group. The sham-operated group was given I.C. saline. Apomorphine-induced circling behavior and histopathology of brain striatum were carried out. Phase 2 was carried out in total 5 groups – sham-operated, disease control, positive control (levodopa), study drug (PEW) low dose (200 mg/kg) and study drug high dose (300 mg/kg). NBTs used were circling behavior, open field, rota rod and stepping test. After 28 days, brain of all rats was used for histopathology and biochemical analysis. Results: Phase 1: There was significant increase in circling behavior in disease control group. On histopathology, significant amount of dopaminergic neuronal loss observed in disease control group (p <0.05). Phase 2: Both doses of study drugs showed significant improvement in variables used in NBTs. In biochemical analysis, both doses of study drug decreased MDA and increased GSH. Histopathology showed that high dose of the study drug prevented neuronal loss (p <0.05). Conclusion: Study drug PEW is protective in 6- OHDA induced PD in wistar rats.
Keywords: Anti-oxidant, joshimath, kampavata, striatum
| » GUFIC-6: Beneficial Effect of Pimpinella anisum Essential Oil in Delaying the Progression of Diabetic Cataract | | |
Bhadada SV, Dave J1, Johar K2
Institute of Pharmacy, Nirma University, 1Torrent Research Centre, 2Department of Zoology, Biomedical Technology and Human Genetics, Gujarat University, Ahmedabad, Gujarat, India
E-mail: [email protected]
Objective: The development of cataract is found to be five times higher as compared to non-diabetics. Essential oil of Pimpinella anisum (Aniseed oil) possess rich content of trans-anethole which possesses good antioxidant property as well as aldose reductase inhibitory activity. The objective of the study was to evaluate the effect in delaying the progression of cataract in diabetic animals. Materials and Methods: Diabetes was induced by high fat diet and low dose streptozotocin (35 mg/kg). The treatment of aniseed oil (250 mg/kg/day, p.o) was given for a period of 10 weeks after induction of diabetes. The development of cataract was examined at the end of 10 weeks. Antioxidant and lenticular parameters were performed in the lens homogenate. Results: Visual cataract was found to be present in only some of the diabetic control rats. High levels of aldose reductase (AR) activity was found to be present in diabetic rat lens as compared to that of control animals. Treatment with Pimpinella anisum essential oil was able to inhibit the AR activity and hence may be helpful in delaying the development of cataract in diabetic condition. This was also supported by improvement in the antioxidant status, protein levels, protein sulfhydryl content and protein carbonyl content of the lens in diabetic treated animals as compared to the diabetic control animals. Conclusions: Our data suggests that Aniseed oil may be beneficial in delaying the development of the diabetic cataract. The effect may be attributing to the aldose reductase enzyme activity and antioxidant activity.
| » GUFIC-7: A Randomised, Open Labelled, Controlled Clinical Study to Evaluate the Anti-osteoporotic Effect of Panchtiktaghrita, a Classical Herbal Formulation in Patients Suffering from Osteopenia | | |
Kumbhar DA, Munshi RP, Panchal FH
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To assess the change in the bone mineral density score, biochemical markers (Sr. Calcium, Vitamin D3, Osteocalcin & Bone specific alkaline phosphatase level between the two study groups at the end of treatment and to assess the clinical safety. Methods: The study was initiated following Institutional Ethics Committee approval. Patients suffering from osteopenia were randomized to one of 2 groups and received either Panchatikta Ghrita formulation + calcium and Vitamin D3 supplements or only calcium and Vitamin D3 supplements after obtaining written informed consent. Monthly assessment included clinical assessment and Ayurvedic symptom score and bio markers were evaluated at the baseline and End of treatment visits. Results: 80 patients were enrolled of which 68 completed the study and 12 patients dropped out from the study either due to adverse event or lost to follow up. Significant improvement in vitamin D3 (p <0.001), Sr. Osteocalcin (p <0.001), and Sr. TRAP-5b (p <0.05), was observed in PanchatiktaGhrita treated group as compared to standard treatment group. Conclusion: Panchatikta Ghrita has shown slow down effect in bone degeneration process and hence it is useful in osteopenia in this study.
Keywords: Osteocalcin, osteopenia, panchatikta ghrita, Sr. TRAP-5b
| » GUFIC-8: Anti-inflammatory and Disease Modifying Activity of Cissus Quadrangularis Linn in Experimental Models by Modulating pro-/anti-inflammatory Mediators and Apoptotic Markers and Phosphorylation of ERK/JNK/p-38 | | |
Rohit Kumar1,2, Ashish Kakkar1,2, Yogendra Kumar Gupta1, Surender Singh1
1Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, 2Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
E-mail: [email protected]
Objectives: Cissus quadrangularis is a traditional medicinal plant used for the treatment of various inflammatory disorders. The aim of present study was to investigate the effect of Cissus quadrangularis hydroalcoholic extract (CQHE) on experimental models of inflammation and arthritis. Methods: Evaluation of anti-inflammatory & anti-arthritic activity of CQHE was carried out using carrageenan-induced paw edema, cotton pellet implantation, complete Freund's adjuvant (CFA)-induced stimulation of peritoneal macrophages and CFA induced arthritis respectively. Anti-apoptotic activity was evaluated in LPS stimulated RAW 264.7 macrophages.Results: CQHE (50-200 mg/kg) produced dose dependent reduction in carrageenan-induced paw edema and cotton pellet-induced granuloma model. Treatment with CQHE significantly decreased expression of pro-inflammatory cytokines, including TNF-α, IL-1β, IL-6, TNF-R1, and COX-2, with an increase in anti-inflammatory cytokine IL-10 in serum and activated peritoneal macrophages. CQHE treatment produced dose dependent reduction in adjuvant induced arthritis, however significant reduction was observed only at 200mg/kg dose as compared to controls. CQHE treatment also inhibited phosphorylation of MAPK signaling pathway as there was decreased protein expression of MAPK (p-p38/p38,p-ERK/ERK and pJNK/JNK ratio) and displayed decreased inflammatory cell infiltration in histopathological findings. Treatment with CQHE in LPS stimulated RAW 264.7 macrophages attenuated apoptosis by inhibiting p53 accumulation, cytochrome-3, caspase 3 activation and by decreasing Bax/Bcl-2 ratio. In inflammation, excess production of NO from iNOS was implicated, therefore levels of NO and iNOS were evaluated and were found to be diminished with CQHE. Conclusion: Based on above results, Cissus quadrangularis was associated with amelioration of several inflammatory and immunological mediators supporting its possible utility in inflammatory disorders.
Keywords: Apoptosis, cissusquadrangularis, inflammation, macrophages, pro-inflammatory cytokines
| » GUFIC-9: Anti-inflammatory Activity of Alkaloids from Murraya koenigii Leaves in Animal Models | | |
Patil RA, Amrutkar SV, Langade P1
Department of Pharmacology, GES's Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research, Prin. T. A. Kulkarni Vidyanagar, 1MGv's Pharmacy College, Nashik, Maharashtra, India
E-mail: [email protected]
Objective: Alkaloids have a wide range of pharmacological properties, including anti-inflammatory activity. The purpose of the present study was to investigate the anti-inflammatory and antioxidant activity of Murraya koenigii leaves. Methods: The hind paw edema was produced in rats by subplantar injection of Carageenan. Pet ether extract (PMK) of Murraya koenigii leaves and alkaloids (AMK) isolated from PMK at doses of 100 and 300 mg/kg/day, p.o. were given for 11 days to observe % inhibition of paw edema which was comparable with Aspirin (100 mg/kg, p.o.) used as a reference drug. Results: PMK and AMK significantly reversed the Carageenan induced decrease in paw Superoxide dismutase (SOD), Catalase (CAT), reduced glutathione (GSH) levels compared to Carageenan treated rats. Lipid peroxidation (LPO) induced by Carageenan treatment was significantly reversed after administration of PMK and AMK. Hematological analysis of carageenan-treated rats exhibited significant decrease in RBC count, Hb content and PCV after treatment with aspirin, compared to the control. PMK or AMK treated animals showed normal erythrocyte (RBC) count, hemoglobin (Hb), packed cell volume (PCV), near to control group. The total leukocyte (WBC), lymphocyte, neutrophils, and basophils count were higher in rats treated with aspirin compared to control. PMK and AMK treatment showed decreased platelet count, activity of ALT and compared to control. Conclusion: A significant decrease in % inhibition of paw edema and alterations in associated biochemical parameters by pet ether extract of Murraya koenigii (PMK) leaves and alkaloids (AMK) isolated from PMK for 11days, suggest its usefulness as an anti-inflammatory agent.
| » GUFIC-10: Durva Swarasa (Cynodon dactylon Linn Pers - juice) Benefits in Menopausal syndrome (Rajonivritti janya vikritavstha) –Reverse Pharmacology | | |
Vandana Singh, Anita Singh, Sara Moncy Oommen1, Dinesh Kumar Bharatraj
Drug Toxicology Research Center, ICMR-National Institute of Nutrition, Hyderabad, Telangana, 1Department of Dravyaguna Vijnan, Government Ayurveda College, Ernakulam, Kerala, India
E-mail: [email protected], [email protected]
Introduction: Menopausal syndrome (M.S.) is increasing by 2-3 folds and it is a public health concern. In Ayurvedic system, MS is co-related with lakshanas of 'Rajonivrittijanya vikrit avastha' and is based on symptoms like hot flushes, night sweating, palpitation, insomnia, irritation, etc. The treatment with Hormone replacement therapy (HRT) has its own disadvantages due to adverse events. Exploring Non-HT alternatives viz. Shatavari, Ashwagandha, Vidari are been focused. We are exploring the role of Durva (Cynodon dactylon) as an effective safe therapeutic agent. Aims and Objective: To evaluate therapeutic benefits of Durva in patients with menopausal syndrome and asses bone mineralization activity in- vitro osteoblast system. Materials and Methods: Ethnobotanical validation of durva (Cynodon dactylon) by taxonomist and preliminary phytochemical analysis. Prepare test formulations (swarasa) as per Ayurvedic pharmacopoeia of India. A Pilot clinical trial in females aged 40-55 with confirmed menopausal syndrome have been subjected for oral administration of Durva- swarasa (15ml) twice daily for a period of one month has been evaluated for beneficial effects on various somatic and psychological symptoms. in- vitro osteoblast activity is determined in SaOS2 cell line. Results: Durva showed a significant effect (<0.01) on somatic complaints, psychological complaints and not effective (>0.05) in the symptom of forgetfulness, loss of urinary control. vaginal cytology indicated the elevated trend in estrogen level.In SaoS2 cell significant 1.5 fold more activity of ALP in durva than standard drug observed. Conclusion: Durva Swarasa can be a potential non-hormonal therapy for MS.
Keywords: Durva, menopausal syndrome, rajonivritti
| » Manjit Singh Prize | | |
| » MAN-1: Molecular Mechanisms Involved in the Protective Effects of Withaferin A in Lung Fibrosis | | |
Chandraiah Godugu, Swarna Bale
Department of Regulatory Toxicology, National Institute of Pharmaceutical Education and Research, Balanagar, Hyderabad, India
E-mail: [email protected]
Objective: Pulmonary fibrosis (PF) is a chronic lung disease with only two FDA approved drugs available clinically. Inadequate therapy motivated us to explore the effect of vimentin inhibitor Withaferin A, as an anti-fibrotic agent against TGF-β1 induced in vitro fibrosis and Bleomycin induced in vivo fibrosis with an emphasis on epithelial to mesenchymal transition (EMT), extracellular matrix (ECM) deposition, inflammation and angiogenesis. Methods: Alveolar epithelial cells and human fetal lung fibroblasts were stimulated by TGF-β1 and treated with Withaferin A (0.25, 0.5 and 1 μM concentrations) to explore possible mechanisms of anti-fibrotic effects. Bleomycin at a concentration of 2 IU/kg was oropharyngeally aspirated to induce fibrosis in murine model and therapeutic potential of Withaferin A (2 and 4 mg/kg) was assessed by initiating treatment one day after Bleomycin administration and continued for 28 days. All the parameters related to PF and molecular studies were performed at the end of treatment period. Results: Withaferin A treatment reduced the progression of PF by modulating EMT related cell markers both in vivo and in vitro. Withaferin A further ameliorated the expression of inflammatory cytokines and attenuated the expression of pro-fibrotic and fibrotic proteins in Bleomycin induced PF by modulating Smad 2/3 signaling. The expression of angiogenic factors in HFL1 cells were also inhibited by Withaferin A. Conclusion: Withaferin A treatment suppressed the expression of pro-inflammatory, pro-fibrotic and pro-angiogenic mediators; also reduced the deposition of ECM proteins. In a nutshell, Withaferin A could probably prove as an efficient and potential therapeutic against PF.
| » MAN-2: Proteomic Analysis of Streptozotocin Induced cell Based Model of Diabetes | | |
Jamadagni PS, Pawar SD, Chougule SV, Jamadagni SB, Gaidhani SN1, Rao G
Regional Ayurveda Institute of Fundamental Research, (Under Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India), Pune, Maharashtra, 1Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India, New Delhi, India
E-mail: [email protected]
Objectives: Study of protein expression in streptozotocin induced cell based diabetes model. Methods: RIN5F (Pancreatic cell line) was treated with 25 mM Streptozotocin (dose decided after cytotoxicity assay) for one hour and later suspended in normoglycemic media for 24 hours. After 24 hrs, cells were harvested and were processed for protein digestion. Samples were subjected to LC- MS analysis and results obtained were analyzed with the help of Uniprot Data base. Results: The results obtained suggested Streptozotocin treatment related up-regulation of Serine/threonine-protein kinase D1 protein, and 3-phosphoinositide-dependent protein kinase 1; and down regulation of Phosphatidylinositol 3, 4, 5-trisphosphate 5-phosphatase 2 (Ptd (3, 4, 5)P3). Ptd (3, 4, 5) P3 plays a crucial role in regulation of PI3K-dependent insulin signaling. Conclusion: The study indicates Streptozotocin treatment at sub-lethal dose (25 mM) to pancreatic cell lines (RIN5F) leads to down regulation of PI3K mediated disturbance in Akt pathway which is crucial in cell glucose metabolism.
| » MAN-3: Methylenetetrahydrafolatereductase Polymorphism in Healthy Volunteers Andits Correlation with Homocysteine Levels in Patients with Thrombosis | | |
Gaur IS, Panchal FH, Munshi RP
Department of Clinical Pharmacology, TNMC and BYL Nair Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To determine the prevalence of MTHFR C677T mutations in apparently healthy Maharashtrian individuals and patients with Deep Vein thrombosis (DVT) and Coronary Artery Disease (CAD) and further to correlate the polymorphisms with homocysteine levels. Methods: This case control study was initiated after obtaining Institutional Ethic committee permission and written informed consent from the participants. The study comprised of healthy volunteers and patients with arterial and venous thrombosis. Prevalence of the C677T mutation was detected using PCR and restriction fragment length polymorphism technique. Serum homocysteine concentration was determined using standardized kits procured from Accurex on fully automated biochemistry analyzer. Results: The frequency of C allele and T allele was 0.95 and 0.06, 0.86and 0.14, 0.97and 0.03 in controls, DVT and CAD respectively. Patients with both DVT and CAD showed increase in homocysteine levels as compared to controls. There was 2.5 and 5.13 times higher risk of homocysteine levels in DVT and CAD respectively as compared to controls with OR=2.494, 95% Cl= 1.285-4.840, p=0.0104 and OR=5.133, 95% Cl= 2.600-10.134, p<0.0001 respectively. Conclusions: The prevalence of mutant variant is more in patients as compared to controls. Our study highlights the fact that MTHFR C677T polymorphism affects the Homocysteine levels in patients with thrombosis which implicates that the patients with mutant variant are at higher risk of rapid progression of their disease condition.
Keywords: Coronary artery disease, deep vein thrombosis, healthy volunteers, homocysteine, Methylenetetrahydrafolatereductase polymorphism
| » MAN-4: Studies on the Role of Hydroxyl Citric Acid in Incretin (Gastrointestinal Hormone) Induced Insulin Release in STZ Diabetic Rats | | |
Eswar Kumar K, Swathi P
AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India
E-mail: [email protected]
Objective: The objective of the present study was to evaluate the influence of Hydroxyl Citric Acid (HCA) on in vivo antioxidant activity, antihyperglycemic activity and its incretin effects in STZ induced diabetic rats. Materials and Methods: The Streptozotocin (60mg/kg bd.wt., i.p) is used to induce the diabetes. The HCA at 50 and 100mg/kg treatment was given orally once in a day. The serum parameter like fasting blood glucose, insulin was estimated at intervals of one week. The lipid profile (total cholesterol, triglycerides, HDL, LDL and VLDL), liver profile (AST, ALT, ALP, total protein and bilirubin), pancreatic and intestinal antioxidant enzymes (SOD, CAT, GSH and GPx) and PCO were estimated. The pancreatic GLP-1R gene expression and hepatic DPP4 gene expression were estimated at the end of 15 days of study period. Histopathology of pancreas and ileum was also done at the end of study period. Results: Treatment with HCA has significantly increase the insulin, lowers blood glucose, HbA1c, TC, TG, LDL and VLDL and increased levels of HDL in STZ induced diabetic rats. The HCA showed increasing the levels of SOD, CAT, GSH and GPx in both pancreas and ileum. The treatment with HCA showed significant increased pancreatic GLP-1 gene expression and decreased hepatic DPP 4 gene expression was found in STZ induced diabetic rats. Treatment with HCA showed marked amelioration of pancreatic and ileum tissue in STZ induced diabetic rats. Conclusion: The incretin effects of HCA might be due to its antioxidant, hepatoprotective, antihyperglycemic activities.
| » MAN-5: Gender-specific Role of CYP24A1 rs2762939 in the Risk of Essential Hypertension | | |
Varakantham V, Ale K, Kurakula Sailoo AK1, Nagalla B2, Bharatraj DK
Food and Drug Toxicology Research Centre, National Institute of Nutrition, 2Department of Biostatistics, National Institute of Nutrition, Hyderabad, 1Department of General Medicine, Gandhi Hospital, Secunderabad, Telangana, India
E-mail: [email protected]
Objective: CYP24A1 (1,25-Dihydroxyvitamin D-24-hydroxylase) belongs to Cytochrome P450 gene family which is responsible for the catabolism of 25-hydroxyvitamin D(3) (25(OH)D) and 1,25-dihydroxyvitamin D(3) (1,25OH2D) to 24-hydroxylated vitamin D products. It is widely known that lower levels of Vitamin D can lead to increased renal renin and angiotensin II production, thus elevating blood pressure or development of hypertension. Methods: We have conducted an investigation on 292 hypertensives and 324 controls to evaluate the association of the genetic variant of CYP24A1 rs2762939 and 25(OH)D in an Indian population with essential hypertension (EH). Results: On gender-based stratification, males were found to carry a 2.586-fold risk (OR=2.586, CI 1.070-6.251, P=0.035) of EH, while 52% of females (OR=0.48, CI 0.231-0.996, P=0.049) were less likely to develop EH in the recessive model (CC vs. GG+CG). In multivariate logistic analysis after adjustment for covariates including age, body mass index, smoking, FBS, total cholesterol, LDL and HDL, the association between the CYP24A1 rs2762939 CC variant and EH has partially increased in males (OR=3.141, CI-1.164-8.478, P=0.024) while females were found to show inverse association with EH (OR=0.398, CI 0.172-0.092, P=0.031). This association was explained by the 25(OH)D levels among the three genotypes of hypertensives and controls. Conclusion: Our results clearly suggest that gender, CYP24A1 rs2762939 genetic variant, and Vitamin D status may play a significant role in disease susceptibility towards hypertension in Indian population. Further, robust pharmacogenetic studies including more number of genes of Vitamin D metabolic pathway and renin-angiotensin system with larger sample size are warranted to draw specific conclusions.
Keywords: CYP24A1, hypertension, risk, rs2762939, sex-specific
| » OD Gulati Prize | | |
| » ODGUL-1: Antiplatelet Effects of Lycopene in Hyperlipidemic Patients: An in vitro Study | | |
Verma AA, Rege NN, Salagre SB1, Patel TC2, Gajbhiye SV, Uchil D
Departments of Pharmacology and Therapeutics and 1Medicine, Seth GS Medical College and KEM Hospital, 2Department of Pharmacology, HBT Medical College and Dr. R N Cooper Municipal General Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objectives: Lycopene, a bioactive ingredient of tomatoes, inhibits normal platelet aggregation. Hyperlipidemic patients, however, have hyperaggregable platelets, with reduced aspirin responsiveness. It was decided to compare effects of lycopene and its combination with aspirin with aspirin alone on aggregation of platelets procured from hyperlipidemic patients. Methods: Following IEC permission and informed consent, platelets were procured from 12 hyperlipidemic patients and exposed to DMSO (vehicle), 140 μmol/L aspirin and 8 and 12 μmol/L lycopene (concentrations selected after platelet viability study). 2.5 μM ADP and 1μg/ml collagen served as aggregating agents. Platelets procured from additional 12 hyperlipidemic patients were exposed to DMSO, 140 μmol/L aspirin, AL1 (aspirin+4 μmol/L lycopene) and AL2 (aspirin+6 μmol/L lycopene+). Maximum platelet aggregation (MPA) and platelet inhibition (PI) were calculated. Statistical analysis of data was carried out. Results: Both, aspirin and lycopene significantly inhibited MPA compared to DMSO (p<0.01) against ADP. 8 μmol/L lycopene had no effect on MPA induced by collagen. However, PI of lycopene was significantly lesser than that of aspirin (p <0.001). MPA values for aspirin alone, AL1 and AL2 were also significantly lesser than DMSO (p <0.01) for both the aggregating agents. With ADP, PI of LA2 was found to be significantly higher than aspirin alone (p<0.05) but not with collagen. Conclusion: Lycopene exerts antiplatelet effect, which is significantly lesser than aspirin. Hence, lycopene cannot be a suitable alternative to aspirin. However, 6 μmol/L lycopene + aspirin showed synergism against ADP induced platelet aggregation, which has therapeutic significance.
Keywords: Cardiovascular disease, hyperlipidemia, light transmission aggregometry, platelet aggregation, tomatoes
| » ODGUL-2: Pharmacogenetic Approach to Predict Response to Statins outcome | | |
Panchal FH, Munshi RP, Kalekar SA, Rajadakshya GC1, Chaurasia A2
Departments of Clinical Pharmacology, 1Medicine and 2Cardiology, TN Medical College and BYL Nair Ch. Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To study the gene variants involved in the pharmacokinetics and pharmacodynamics of Statin therapy and to correlate the genetic variations with the variations in the various biochemical parameters which may help determine the effectiveness of Statins in modulating risk of cardiovascular events with a reduction in their toxicity profile. Methods: Institutional Ethics Committee permission was obtained prior initiation of the study. Patients attending Cardiology and Medicine OPDs of tertiary care hospital and receiving a stable dose of Atorvastatin for duration of 6 weeks were enrolled after written informed consent. We studied the genotype phenotype association in response to statin in 406 CAD patients. Genotyping of all SNPs were performed using PCR-RFLP method except for SLCO2B1 gene was performed using Taqman genotyping assays. Lipid profile and Creatinine Kinase was performed on automated biochemistry analyzer. Results: The allele frequency observed for CYP3A4, CYP3A5, SLCO1B1A388G, SLCO1B1T521C, SLCO2B1C1457T, CETP and Apo E were 2%, 76%, 52%, 2%, 7%, 44%. respectively. The allele frequencies for ApoE isoforms wereε2-0.99, ε3-94.95 and ε4-4.06 respectively. Increased levels of lipid markers were observed in minor variants as compared to wild alleles. The variant of SLCO1B1rs2306283 and SLCO1B1 rs4149056 had 3.34 and 2.01 times higher risk of increased CK levels as compared to the normal homozygous genotype. Conclusions: The results suggest that SNP in statin pathway will help in identifying individuals who may resistant to lipid lowering by statin. Also the genotype association impacts the cardiac risk which would ultimately optimize the drug therapy and minimizing the drug toxicity.
Keywords: Coronary artery disease, myopathy, SNPs, statin
| » ODGUL-3: Monitoring of Myalgia in Cross Sectional Population using Statin and their Vitamin D Status | | |
Ale K, Banjara SK, Sravan P1,Bindela M, Bharadwaj DK
Drug Toxicology Research Centre, ICMR-National Institute of Nutrition, 1Osmania General Hospital, Hyderabad, Telangana, India
E-mail: [email protected]
Introduction: Myalgia is one of the most frequent adverse events of statins. In vitamin D deficiency also myalgias are common. In India, the statin use has increased enormously in various dose strengths. However there are no substantial reports to confirm the myalgias due to statin usage. Therefore, the objective of the study is to assess myalgia and other related adverse events in cross sectional population using statins along with vitamin D status. Methods: Subjects reporting to tertiary care hospital for chronic ailments and receiving statins were enrolled to collect the information on use of statins and other clinical parameters viz., Lipid profile, ALP, Ca, P, Uric acid and Creatinine Kinase. The data has been collected in a pretested schedule following WHO guidelines. Vitamin D status has been determined by ELISA. Myalgia has been assessed by Lafayette manual muscle tester as per MRC (Medical research council) scale. Results: The subjects include males (38%) and females (62%) in a mean age of 52.4±9.8 and 48.7±8.3 respectively. The various doses of statins used were 10 mg (44%), 20mg (48%) and 40mg (8%). The severe (8%) and moderate myalgia (34%) was assessed by muscle tester. The mean CK levels were normal in 90% of patients. The mean Vitamin D levels in myalgic and non myalgic were 12.9 ± 6.12 ng/μl and 14.4±7.53 ng/μl respectively. The causality assessment suggests 13% had confirmed myalgia. Conclusion: The statin and myalgia reporting is therefore necessary in Indian population who are having the added constrain of vitamin D deficiency.
| » ODGUL-4: Anti-arrhythmic Effect by Targeting Ca2+/Calmodulin (CaM)-dependent Protein Kinase II (CaMKII) Pathway | | |
Solanki A, Pardeshi M, Bhatt LK
Department of Pharmacology, SVKM's Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Excessive levels of Ca2+/calmodulin (CaM)-dependent protein kinase II (CaMKII) are potential contributors in arrhythmia. Inhibition of CaMKII would benefit in the treatment of arrhythmia. Methods: The present study investigated the antiarrhythmic activity of combination of drug, Dantrolene sodium (Ryanodine receptor antagonist) and Polymyxin B (calmodulin antagonist) by using CaMKII pathway in CaCl2 induced arrhythmia.CaCl2 (90 mg/kg) was administered by intravenous infusion (IV) to produce arrhythmia in rats. The animals were then treated with atenolol (5 mg/kg, iv) and individual drug and combination of Dantrolene (5mg/kg) and Polymyxin B (0.5mg/kg). Lead II electrocardiogram was monitored. Plasma LDH and CK-MB level was determined. Ventricular tachycardia, ventricular fibrillation, flutter, ectopic beats was evaluated for its incidence and duration. Results: The results showed a decrease in premature ventricular contraction, fibrillation incidence and duration and flutter incidence and duration in combination group as compared to negative control group. Notably, arrhythmia scoring was decreased in combination group compared to negative control. Also there was a decrease in CaMKII levels in combination group compared to negative control. Significant decrease in Lactate dehydrogenase (LDH) and creatinine kinase MB levels were noted in combination group as compared to negative control. Conclusion: The results suggest that Inhibiting CaMKII using calmodulin antagonist, Polymyxin B and controlling release of calcium ion from sarcoplasmic reticulum by inhibiting ryanodine receptor using Dantrolene sodium could be a therapeutic approach for the treatment of arrhythmia.
| » UK Seth Prize | | |
| » UK SETH-1: Off-site Suspected Serious Adverse Event Reports: Impact on Ethics Oversight | | |
Chaitali Pilliwar, Raakhi Tripathi, Shruti Bhide, UrmilaThatte1, Prajakta Auti2
Departments of Pharmacology and Therapeutics and 1Clinical Pharmacology, Seth GS Medical College and KEM Hospital, 2Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To analyze all the SUSAR reports (i.e. off site SAE reports)received by IEC for review of causality assessment stated by principal investigators (PIs) and sponsors and evaluate the degree of agreement among them. Also, action taken by the IEC towards the SUSAR report was also evaluated. Materials and Methods: SUSAR reports submitted to the IEC between October 2013 and December 2014 were reviewed. The off site SAE reports were evaluated for different study criterias such as number of SUSAR received / project, number of initial and FU reports / project, number of specific offsite SAE based on SAE term classification, assessment of causality by PI and sponsor, IEC Review process of the off site SAE reports in terms of number of meetings and number of reports reviewed per meeting and action taken by IEC. Results: 1583 SUSAR reports were analyzed. The median number of SUSAR reports per project is 42. Maximum SAE offsite reports were received from drug trials of endocrine diseases and least number with cardiac diseases trials. Causality agreement matched in 852 / 1583 (53%) reports between PI and sponsor. Mean duration of SAE subcommittee meetings was 31.87 ± 6.95 mins and mean number of agenda items was 1.8 ± 0.65. Median number of off site SAE reports reviewed per meeting were 12. Conclusion: The offsite SAE reports form a major document burden for EC and does not receive the vigilant scrutiny as the onsite SAE report.
Keywords: Pharmacovigilance, SAE, SUSAR
| » UK SETH-2: Use of Topical Steroids in Dermatology – A Questionnaire Based Study | | |
Karekar SR, Marathe PA, Nagarajan V, Khopkar U1, Chikhalkar S1
Departments of Pharmacology and Therapeutics and 1Dermatology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Background and Objective: Topical corticosteroids (TCs) are the most commonly prescribed drugs in Dermatology and are often misused. This study was done to assess awareness of patients about use of TCs and to analyse their prescriptions. Methodology: Following ethics committee permission and informed consent, 200 patients with prescriptions of TCs were enrolled from Dermatology OPD of a tertiary care hospital in a cross sectional study. Awareness of patients, patterns of TC use and prescriptions (indications, types) were assessed. A pre-validated questionnaire was used. Data was analysed using descriptive statistics and Chi- square test. p value was set at <0.05. Results: Out of 200, 119 patients were prescribed TCs in the OPD and 81 from outside. Of all, 7% patients had asked the doctor about drug prescribed and 4.5% knew side effects. Only 42% of them knew the condition for using TCs and 47% were aware of requirement of a prescription for purchase. Psoriasis was the most common indication followed by Tinea and Vitiligo Almost 38% patients obtained TCs over the counter while 16% used old prescriptions. Compared to institutional prescriptions, patients having outside prescriptions complained of more side effects, showed incorrect and irrational use (FDC for Tinea infection), relapse, over the counter use and use without expert supervision. Conclusion: The study revealed a major lack of awareness among patients using TCs. Better awareness and rational prescribing practices were observed among those prescribed from the hospital OPD. Use of TCs needs close supervision and patients should be adequately instructed.
Keywords: Awareness, fixed dose combinations, steroid abuse, topical steroids
| » UK SETH-3: Introducing Pharmacoeconomics in the Pharmacology Curriculum for Medical Undergraduates: A Prospective Questionnaire Based Study | | |
Jois P, Kulkarni U, Shetty YC, Brahma S, Rege NN, Khopkar U1
Departments of Pharmacology and Therapeutics and 1Dermatology, Seth GS Medical College and KEMH, Mumbai, Maharashtra, India
Objective: Lack of awareness about the economic reality drug therapies may cause prescribing costly drugs or brands to patients especially, the economically poor. This may lead to poor patient compliance resulting in increased morbidity and mortality rate. With this background, we decided to conduct this study with the following objectives, (a) To find out the knowledge of the second-year medical students about pharmacoeconomics (PE). (b) To familiarize the students with literature on PE. (c) To make the students aware of cost consideration of drug therapy. Materials and Methods: After approval from the Institutional Ethics Committee, the study was conducted in 106 2nd MBBS students who volunteered to consent and participate in the study. After a pre-test a teaching module, taking psoriasis as an example was delivered to the students followed by the post test. The pre-test and post-test questionnaires containing same 15 questions were validated by 8 experts with a CVR (content validation score) of 0.7. At the end a plenary session containing 5 case scenarios of psoriasis with 7 questions were given to the students to be answered in groups of 8-9 per group. The results were analysed by descriptive statistics. Results: The mean percentage scores of the participants in the pre-test was 43.26 which increased to 74.66 in the post test (p<0.0001) in the paired t-test. In the plenary session, 3 out of 12 groups scored 85.68% and the least score was 57% by 3 groups. Conclusion: As the pre-and post-project data differs significantly, it shows that the awareness about PE is evolved in the participants. Hence the future prescribers, would appreciate the cost effectiveness of drug therapy, which may help to reduce the economic burden of healthcare.
Keywords: Medical curriculum, pharmacoeconomics, undergraduate medical students
| » UK SETH-4: Prescription Monitoring of Patients with Psoriasis Visiting Dermatology OPD of the Public Tertiary Care Hospital | | |
Chitnis K, Kulkarni U, Shetty YC, Rege NN, Chikhalkar S1, Koli P, Khopkar U1
Departments of Pharmacology and Therapeutics and 1Dermatology, GSMC and KEMH, Mumbai, Maharashtra, India
E-mail: [email protected], [email protected]
Introduction: Psoriasis is a chronic inflammatory skin disorder marked by relapse and remissions. Drug studies are required to understand the prescription pattern. Objective: To study prescriptions of clinically diagnosed cases of psoriasis attending dermatology OPD in a public tertiary care hospital. Materials and Methods: After taking institutional ethics committee permission, 805 prescriptions were screened to collect prospective data between Dec 2010 and June 2012, out of which, 131 were enrolled. 580 prescription records were screened between Jan 2011 to June 2012 to collect retrospective data. Out of which, a total of 169 were considered. For retrospective data collection, therapy prescribed on last follow up visit was recorded. Patient record form was reviewed for important patients, disease and drug related information. Results: Mean age of patients was 41.40±16.38. Males and females constituted 66% and 34% respectively. Psoriasis vulgaris (62.72%) was the major diagnosis. Topical emollient and topical steroids along with antihistamine were commonly used therapy followed by systemic therapy (along with topical agents) where Methotrexate was the most commonly used. Average number of drugs per prescription was 5. 25% patients tried Ayurveda for psoriasis as alternative treatment. Majority of the prescriptions were incomplete in context to strength of drug, duration and language in which patient understands. Conclusion: Five drugs were prescribed per prescription frequently consisting of Topical emollient and topical steroids along with antihistamine.
Keywords: Completeness, methotrexate, prescription audit, psoriasis, rationality
| » UK SETH-5: Prescription Audit of Anti-fungal Treatment of Dermatophytoses in the Dermatology Out-patient Department of a Tertiary Care Hospital | | |
Brahma S, Shetty YC, Dongre M, Jage M1, Rege NN, Khopkar U1, Dandekar S2
Departments of Pharmacology and Therapeutics, 1Dermatology and 2Biochemistry Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To study the prescriptions of clinically diagnosed cases of dermatophytoses, to evaluate medical treatment of clinical failure cases, any rise in serum ALT (Alanine aminotransferase) levels associated with usage of oral anti-fungal drugs, availability of drugs in the hospital pharmacy and cost minimization of different oral treatment regimens with Griseofulvin, Fluconazole, Itraconazole and Terbinafine. Materials and Methods: 370 patients from the Dermatology Out Patient Department (OPD) were enrolled in a single centre prospective cohort observational study. Follow-up was done 3±1 weeks apart, twice for newly diagnosed patients and once for patients on ongoing therapy. Two separate blood samples were collected 3±1 weeks apart for estimation of serum ALT. The prime lesion in each patient was graded as mild, moderate and severe. Patients were categorized as clinically cured, clinically improved, or as clinical failure following treatment. Results: Azoles were the most commonly prescribed antifungals. Clinical status of patients was independent of the oral antifungal drug received (p > 0.05). A statistically significant difference in clinical status between compliant and non-compliant patients was seen (p < 0.05). A statistically significant increase in serum ALT levels was seen (p < 0.05) however, it was not clinically significant. 55.52% of drugs were unavailable in the hospital formulary. The average expenses per prescription was approximately INR 1123.55. Itraconazole was the most expensive treatment regimen followed by terbinafine and fluconazole. Conclusion: There exists a non-uniformity in the management of dermatophytoses due to lack of adequate guidance and non-availability of drugs and clinical cure of patients depends upon compliance to therapy.
Keywords: Anti-fungals, cost minimization, dermatophytoses, prescription-audit, treatment
| » UK SETH-6: An Observational Study to Determine the Adverse Drug Reaction Profile of Indoor Patients Suffering from Haematological Malignancies in a Tertiary Care Hospital | | |
Putrevu KN, Kamat SK, Rege NN, Mohite AB1, Kamble AP, Shanmukhaiah C1
Departments of Pharmacology and Therapeutics and 1Haematology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: i) To assess the causality of adverse events (AEs) occurring in patients being treated for haematological malignancies ii) To classify the adverse drug reactions (ADRs) according to the WHO-System Organ Classification (WHO-SOC) iii) To assess the incidence, severity and preventability of the ADRs. Methods: An observational study involving 108 patients was conducted in the haematology ward of a tertiary care hospital. IEC approval and written informed consent from patients was obtained. Patient enquiry and review of treatment records was done to identify any alteration in clinical signs and laboratory values. These were noted as AEs and their causality assessment was done using WHO-UMC scale and Naranjo algorithm. ADRs were classified according to WHO-SOC. Severity was assessed using the modified Hartwig-Siegel scale and Common Terminology Criteria for Adverse Events (CTCAE) grading and preventability by the modified Schumock-Thornton scale. Descriptive statistics were used to analyze this data. Results: Of the 983 AEs that occurred in the patients, 639 were ADRs. Of these ADRs, 13% were found to be 'probably' and 87% 'possibly' related to the cancer chemotherapy with both, the WHO-UMC scale and Naranjo algorithm. 41% of the ADRs belonged to the system organ class -'Investigations'. Leucopenia and anaemia were the commonly seen ADRs in 92 and 90 patients respectively. Most of the ADRs were moderate in severity. Only 9% percent of the ADRs were preventable in nature. Conclusion: Majority of the ADRs occurring in patients with haematological malignancies were of moderate severity and were 'possibly' related to the drugs, the most common being leucopenia and anaemia.
Keywords: Adverse drug reactions, chemotherapy, haematology
| » UK SETH-7: Audit of Project Proposals Submitted to Ethics Committee to Assess Measures Taken to Address the Issue of Vulnerability among Research Participants | | |
Gajbhiye SV, Jalgaonkar SV, Marathe PA, Tripathi RK, Shetty YC, Surve S
Introduction: It is responsibility of ethics committee members and investigators to safeguard the vulnerable population in the study. Objective of the study is to review proposals with vulnerable group submitted to ethics committee and assess whether they protect vulnerable group. Also what type of queries have been raised by ethics committee in relation to safeguarding the population. Methodology: IEC permission was taken. All proposals submitted to IEC for initial review in the period between Jan 2015 to Dec 2016 where vulnerable population has been taken as research participants were considered for inclusion in the proposal. The checklists for assessing the proposal were designed and validated. The IEC query letters were assessed to identify which issues related to vulnerability in the protocol were communicated to the investigator. Results: The total proposals with vulnerable population in the last two years submitted for IEC review were 364. 69 proposals submitted had students/employees as vulnerable group. Amongst them, 33% have not provided adequate scientific justification, 26% proposals did not explain relevance of selecting this population and recruitment policy is not stated in 20% proposals. Similar findings were also noted for other vulnerable groups. The Ethics committees have raised issues of study rationale, selection of study participants, issues of compensation and risk mitigation. However, issues related to recruitment of study participants, reconsent and both parents consent in more than minimal risk studies were missed by IEC. Conclusion: The research proposals submitted to IEC are deficient in measures taken to protect the vulnerability of the research participants. There is a scope of improvement for the IEC to identify the issues regarding protecting vulnerable subjects.
| » UK SETH-8: Perceptions of Social Scientists of Ethics Committee Regarding their Role and Current Practices in the State of Maharashtra | | |
Singh VK1,2, Shetty YC1,2, Jadhav U1,2, Katkar J1,2
1Department of Pharmacology and Therapeutics, Seth GSMC and KEMH, Mumbai, 2MUHS, Nashik, Maharashtra, India
E-mail: [email protected]
Objective: The objective of the present research is to study the contribution of SSst while serving CDSCO registered IECs in the state of Maharashtra, India. Methodology: This was prospective cross-sectional web based online survey where SSst of IEC of 6 zones in the State of Maharashtra contacted through emails from the period of July 2016 to July 2017 after approval from IEC of GSMC & KEM hospital. A validated questionnaire administered comprising questions on SSst profile, role, perception, bioethical knowledge and their contribution while serving IEC in the State. Results: Overall, 23 SSst from 12 districts across various zones [Vidarbha =1, Marathwada = 4, Nagpur =1, Pune =6, Mumbai = 11] responded. 69.56% (n= 16) respondent reported that they did not receive any formal training before joining IEC & as a result 8.69% (n=2) participants are able to follow scientific and bioethical part of research projects and 60.89% (n=14) felt intimidated in IEC meetings. Only 13.04% (n=3) of SSst were actively engaged in serious adverse events committee discussion which oversee the infringements of participants rights and accord due compensation to them. Ambiguity in terms of their role in IEC was noted, as 61% of SSst did not answer to questions posed. Conclusion: Qualitative exploration of SSst views on functioning of IEC underlines imperativeness of training in bioethical aspects to achieve benchmark in reviewing biomedical protocols.
Keywords: Ethics committee, non-technical members, social scientist
| » UK SETH-9: Evaluation of Analgesic Activity of Single and Multiple Doses of Rosuvastatin in Healthy Adult Participants using Radiant Heat Pain Model - A Randomized Double Blind Placebo Controlled Cross-over Study | | |
Lanke VM, Padhy S, Pingali U
Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: Animal studies show that statins have analgesic and anti-inflammatory activity independent of lipid lowering. On review of literature, no studies on healthy subjects were available. Objective of our study was to explore analgesic effect of single and multiple doses of rosuvastatin20mg in healthy volunteers using radiant heat pain model. Methods: After EC approval and informed consent, volunteers were randomized to receive either rosuvastatin20mg or identical placebo in double blinded manner under fasting. Mean pain threshold and tolerance times were recorded at baseline and 2 hours post drug administration on day 1 for single dose study. Drugs were administered under supervision daily for 7days and same test procedure repeated on day 8 for multiple dose study. After 2 weeks washout subjects crossed over to other formulation and same procedure repeated. Statistical analysis was done with SPSS17.0. Results: 18 subjects (12 males, 6 females), mean age 32.33±2.44years participated. Compared to baseline, rosuvastatin produced significant (p<0.001) increase in pain threshold and tolerance times with single and multiple doses. Single dose rosuvastatin produced highly significant (p<0.001) increase in pain threshold (24.5%) and pain tolerance (23.5%) compared to baseline. With multiple dose, pain threshold increased by 8.8% (p<0.001) and pain tolerance by 9.1% (p<0.001) compared to baseline. Compared to placebo, rosuvastatin in both doses produced highly significant (p<0.001) increase in pain threshold and tolerance. Both treatments were well tolerated. Conclusion: Rosuvastatin demonstrated significant analgesic activity compared to baseline and placebo following single and multiple doses. Multiple dose rosuvastatin improved pain threshold and tolerance even at baseline suggesting probable analgesic action. Its role in relieving pain can be explored further.
Keywords: Analgesic, healthy volunteers, radiant heat pain model, rosuvastatin
| » UK SETH-10: Investigation into the Effect of Ghrelin Gene Polymorphism with Weight Loss after Bariatric Surgery | | |
Rawal H, Dave S, Patel V, Narwaria M1, Appasundaram S2, Priya M2, Goyal RK3, Patel BM
Department of Pharmacology, Institute of Pharmacy, Nirma University, 1Asian Bariatrics Hospital, Ahmedabad, Gujarat, 2V ClinBio Labs Pvt Ltd, Chennai, Tamil Nadu, 3Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India
E-mail: [email protected]
Background and Objective: Certain previous studies report that weight loss after bariatric surgery is related to genetic polymorphism. These genes are associated with weight loss after bariatric surgery. The aim of this investigation was to investigate into the effect of ghrelin gene with weight loss after bariatric surgery. Methodology: This study included diabetic and non-diabetic patients registered at Asian Bariatric Pvt. Ltd. A total of 40 diabetic and non-diabetic patients those who were willing to give written informed consent, were enrolled in the study. Blood collection of the patients was done and their lab investigation data were collected. The small portion of stomach sample was taken, DNA was isolated and SNPs of rs9819506 and rs490683 was determined. Results: Out of 17 samples analyzed for rs9819506, 7 patients had wild type homozygous (C/C); 7 patients were wild type showed heterozygous (C/T) and 3 had showed mutant (T/T). The reduction in BMI in rs9819506 CT genotype was more is compared to CC and TT genotype. Out of 19 samples analyzed for rs490683, 10 patients had wild type homozygous (G/G) and 9 patients were wild type showed heterozygous (G/C). The G/G subtype had significant reduction in BMI as compared to G/C. Moreover, reduction in %HbA1c in rs490683 GC genotype was more as compared to GG genotype. Conclusion: The patients with rs9819506 CT genotype had maximum weight loss and patients with rs490683 GT genotype had best glucose control as revealed from HbA1c% levels. However, further studies are registered with large sample size to confirm the result and establish that there is causal relationship between SNPs and weight loss.
Keywords: Bariatric surgery, diabetes, ghrelin gene polymorphism, weight loss
| » UK SETH-11: Corticosteroids Decrease Serum Survivin, M30 Apoptosense and CD28 and Improve Quality of Life in Patients of Asthma | | |
Lalit K Gupta, Shashikant Bhargava, Anubhuti Gupta, Harmeet S Rehan, Anupam Prakasha
Department of Pharmacology, Department of Medicine, Lady Hardinge Medical College and Smt. S.K. Hospital, New Delhi, India
E-mail: [email protected]
In spite of corticosteroids being the first line drug treatment for asthma symptom control, the mechanisms of action of corticosteroids in asthma are still poorly understood. This study evaluated the effect of systemic corticosteroids on serum level of apoptotic markers Survivin (for inflammatory cells) and M30 apoptosense (for bronchial epithelial cells) in patients of acute exacerbation of bronchial asthma and the effect of inhaled corticosteroids (ICS) on the levels of CD28 in mild to moderate chronic asthma. The study involved 60 patients with acute exacerbation of bronchial asthma who were prescribed systemic corticosteroids and 40 asthmatic patients of mild to moderate severity started on ICS alongwith 40 healthy controls. The mean baseline serum Survivin and M30 apoptosense levels (measured by ELISA) were 224.10±42.76 U/l and 123.00±18.79 U/l respectively which decreased significantly (p <0.05) to 111.20±32.26 and 29.67±7.53 U/l after 7 days of oral prednisolone treatment. Serum CD28 concentration in asthmatic patients was 107 ± 4.98 ng/ml which was significantly elevated (p<0.01) as compared to healthy individuals (37.67 ± 18.28 ng/ml). ICS treatment for 4 weeks reduced serum CD28 levels to 40.9 ± 2.82 ng/ml. Corticosteroids also significantly improved QOL (quality of life) scores and PEFR% (peak expiratory flow rate %) in the both acute and chronic asthma patients. Results from the study suggest that systemic corticosteroids decrease survival of inflammatory cells and increase that of bronchial epithelial cells. Serum CD28, a marker of inflammation, is raised in chronic bronchial asthma and is reduced by ICS therapy.The study has been registered with Clinical Trials Registry-India (CTRI/2014/08/004833 & CTRI/2015/07/005977).
Keywords: Apoptosis, asthma, CD28, corticosteroids, M30 apoptosense, survivin
| » Oral Presentations Clinical Oral | | |
| » CPO-1: Evaluation of Drug Use and Adverse Drug Reactions in HIV Patients with Different Opportunistic Infections in a Tertiary Care Hospital in Assam | | |
Debashri, Gohain Kalpana
Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Srimantanta Sankaradeva University of Health Sciences, Guwahati, Assam, India
E-mail: [email protected]
Objective: To evaluate drug use and adverse drug reactions in HIV patients with different opportunistic infections in a tertiary care hospital in Assam. Methods: A retrospective observational study of 1 year duration was done in Assam medical college, Dibrugarh. 120 cases were collected who were HIV positive with opportunistic infections. They were assessed for HAART regimen used, opportunistic infections and adverse drug reactions . The data was analysed and expressed in percentage. Results: Out of the 120 cases included, 88 were males (73.3%) and 32 were females (26.6%). Majority of the drugs were prescribed in oral dosage form. Most common HAART regimen followed was a combination of zidovudine, lamivudine and nevirapine in 76 patients(63.3%). Most common opportunistic infections included—tuberculosis 56 cases(46.6%) and oral candiadiasis in 45(37.5%) cases. Most commonly used drugs are—antimicrobial agents in 98 cases (81.6%) and ATT in 42 cases(35%) . 98(81.6%) cases reported with side effects from HAART, most commonly- lowered heamoglobin in 78 cases(65%), skin rashes in 58 cases (48.3%), fever in38 (31.6%) cases. Conclusion: Study results suggest that prescribing pattern is in accordance with NACO. Use of multiple medicines result in toxicity as well as non-adherence to treatment. Proper awareness among the patients help in reducing treatment failure.
| » CPO-2: Evaluation of Efficacy and Safety of Silodosin in Comparison to Tamsulosin in Patients with Benign Prostatic Hyperplasia-A Randomized Open-label Study | | |
Gupta R, Malhotra A1, Malhotra P1
Department of Pharmacology and Therapeutics, Government Medical College, 1Department of Pharmacology and Therapeutics, ASCOMS and H, Jammu, Jammu and Kashmir, India
E-mail: [email protected]
Background: Benign Prostatic Hyperplasia (BPH) is one of the most common conditions affecting quality of life in older men through bothersome lower urinary tract symptoms (LUTS). Selective α1-adrenergic antagonists are now first-line drugs in the medical management of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, tamsulosin and silodosin are generally preferred in the symptomatic therapy of BPH. Objective: To compare the efficacy and safety of Silodosin in comparison to Tamsulosin in symptomatic benign hyperplasia of prostate (BPH). Materials and Methods: A comparative randomized open-label trial of 6 month duration was conducted on patients attending the Surgery out-patient department of ASCOMS & H, Sidhra, Jammu. Patients were registered after taking written informed consent and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were randomized to two groups to receive either tamsulosin 0.4 mg controlled release capsule or silodosin 8 mg once daily capsule after dinner for 12 weeks. The treatment response was monitored at 2, 4, and 12 weeks. Uroflowmetric parameters and American Urological Association Symptom Score (AUASS) were recorded at 2, 4 and 12 weeks, whereas ultrasound was reassessed only at 12 weeks. Vital signs (Pulse and Blood Pressure) and treatment emergent adverse events were recorded at all the visits. Results: The study was conducted on a total of 44 patients, 22 patients in tamsulosin group (Group I) and 22 patients in silodosin group (Group II). Final AUA SS at 12-week was significantly less than baseline for both groups p<0.05).However, groups remained comparable in terms of AUASS at all visits. A statistically significant improvement in Maximum flow rate (Qmax) was seen with tamsulosin and sildosin from baseline at 12 weeks (p<0.05).However, the intergroup differences in Qmax were not statistically significant (p>0.05). Prostate volume however, did not change in either of the groups as well as in intergroup comparison (p>0.05). Both treatments were well-tolerated. The commonest adverse drug effects encountered in the silodosin group was Dyspepsia and Abnormal ejaculation whereas Headache and postural hypotension were more commonly seen in the tamsulosin group. However, when both the groups were compared, the difference between the two was observed to be non-significant (p>0.05). Conclusion: Tamsulosin and silodosin showed similar efficacy in symptomatic management of BPH with good tolerability, acceptability, and minimum hemodynamic adverse effects.
Keywords: Benign prostatic hyperplasia, silodosin, tamsulosin, α1-blockers
| » CPO-3: Antimicrobial Utilization in Wound Infections in a Tertiary Care Hospital | | |
Rachamanti R, Vemuri PK, Das MC
Department of Pharmacology, NRI Academy of Medical Sciences, Guntur, Andhra Pradesh, India
E-mail: [email protected]
Objective: To identify the utilization of antimicrobials in patients with suspected wound infections according to WHO (World Health Organization) drug utilization indicators. Methods: This is a cross-sectional, record based study conducted in a tertiary care hospital after obtaining Institutional Ethical Committee approval. Patients of all ages admitted into N.R.I Hospital between June to October 2017 having wounds were included in this study. Data of patients was collected from Medical records Department of the hospital. Results: Analysis was done on 100 patients basing on inclusion criteria. Among them, 69 were positive for bacterial culture of wound or pus swab. Wound infections were found to be more common in males and in age group 45-55 yrs. Evaluation of prescriptions based on WHO drug use indicators showed that a total 198 antimicrobials were prescribed for 100 patients. Average no. of antimicrobials per patient were 1.98. 45% of antimicrobials were prescribed by their generic name. 54% were in the form of injections. 93% were in list of essential medicines. Average duration of treatment given was 7±3 days in the hospital. 98 % patients recovered well and got discharged. Conclusion: The results obtained will be useful for implementing the modifications in the prescription for the betterment of the patient and for the community.
Keywords: Antimicrobials, W.H.O indicators, wound infections
| » CPO-4: Comparison of Cytotoxic Efficacy of Cleistanthin a and Cleistanthin B in Tumour Cell Lines Using MTT Assay | | |
Shetty KS, Hogade AP, Mishra S
Department of Pharmacology, Jawaharlal Nehru Medical College, KLE University, Belagavi, Karnataka, India
E-mail: [email protected]
Objectives: This study was designed to compare the efficacy of test drugs Cleistanthin A, Cleistanthin B and the standard anti cancer drug 5-Fluorouracil on cancer cell lines of Ehrlich's ascitic carcinoma using MTT assay. Methods: The 4 compounds used for the study comparison were Cleistanthin A and Cleistanthin B isolated from the tropical plant Cleistanthin Collinus, the defatted extract from the same plant containing both compounds and the standard anti cancer drug 5-Fluorouracil. They were each added to tumour cells of Ehrlich's ascitic carcinoma in doses of 500, 250, 125, 62.5, 31.25 and 15.625 μg/ml. The cell cultures with serial dilutions were then incubated for 72 hours on 2 plates containing 96 wells to compare their potential cytotoxicities against the tumour cells. The medium was then removed, 20 μl of MTT was added to the plates and the cells were incubated for another 4 hours. After incubation, MTT was removed, 1% DMSO was added and cell viability was assessed in a Lisa plus microplate reader with wavelength of 492 nm. Results: IC50 values after 72 hours for plain extract (E), Test compound Cleistanthin A (A), Cleistanthin B (B) and standard drug 5-Fluorouracil (S) were 12.07, 10.42, 3.36 and 348.4 respectively. Conclusions: Both the test compounds Cleistanthin A and Cleistanthin B along with the extract that contained both these compounds showed potent efficacy in killing the cancer cells. Cleistanthin B showed higher efficacy compared to both Cleistanthin A and 5-Fluorouracil. Hence it can be tested further for new advances in cancer chemotherapy.
| » CPO-5: To Evaluate the of Impact of Teaching P-drug Selection as a Task Based Learning in Pharmacology among Second Year under Graduate Medical Students and their Feedback | | |
Harish G Bagewadi, Patil Banderao V
Department of Pharmacology, Gulbarga Institute of Medical Sciences, Kalaburagi, Karnataka, India
E-mail: [email protected]
Objectives: The knowledge of Personal-drug (P-drug) selection process is a vital step towards rational prescribing. This study evaluates the impact of teaching P-drug selection process in 2nd year undergraduate medical students as a task based learning process. Student's feedback serves as the best yardstick for the assessment of teaching/learning activity. Materials and Methods: This was an interventional study conducted among 2nd year medical students. Total of (n=116) students participated in the study. Initially, P-drug concept was taught to all the students in the form power point guided lecture. Then, students were divided into two groups. Later, group B students were participated in the task based activity by enlisting the P- drugs for the commonly diagnosed ailments. After six months of the intervention, we assessed the student's analytical skills, application of their knowledge regarding P-drugs selection. The generated data were tabulated as counts and percentages. Chi-square test was utilized for the statistical analysis. Feedback from the students was also taken. Results: Better understanding of the P drug selection process was opined by group B students when compared to group A with high statistically significance (p< 0.05). Majority of 72% of the students from group B were able to correctly rearrange the steps in choosing the P-drugs which was found to be significantly high (p< 0.05) in comparison to group A. Majority of 70% of the students considered that patient related parameters are prime focus in establishing the suitability of drug Vs. 54 % from group B students. 47% from group B were of the opinion that drug related factors were vital parameters vs. 22% form group a students. 80% of the students opined that prescribing cost effective medicines and their boost in their self-confidence were the prime benefits of undergoing P-drug task based activity. Conclusion: Student's feedback from interventional group was constructive and encouraging. Participating in the task based learning activity enriched them with analytical, reasoning skills involved in rational prescribing and will definitely help in their clinical practice.
| » CPO-6: Clinical Study to Compare the Effect of Antidepressant Drugs (Escitalopram and Sertraline) on Depression Improvement and Biomarker Alterations in Patients of Multidrug Resistant Tuberculosis with Depression | | |
Singh VK, Kushwaha V, Agrawal P, Dixit RK1, Gupta A, Kumar A, Chaudhari D2, Kumar A3
Departments of Pharmacology, 2Psychiatry and 3Tuberculosis and Respiratory Diseases, G.S.V.M. Medical College, C.S.J.M. University, Kanpur, 1Department of Pharmacology, King George's Medical University, Lucknow, Uttar Pradesh, India
E-mail: [email protected]
Objective: To compare the effect of Escitalopram and Sertraline on depression improvement and biomarker alterations in patients of MDR-tuberculosis with depression. Methods: A randomized clinical trial was carried out in department of tuberculosis & respiratory diseases and department of psychiatry G.S.V.M. Medical College, Kanpur after getting approval from the institutional ethics committee. Total 50 MDR-TB patients diagnosed with mild to moderate depression were enrolled in the study and randomly divided into two groups. First group (25 patients) was administered Escitalopram (10mg) and second group (25 patients) was administered Sertraline (50mg) along with standard MDR-tuberculosis treatment. Depression improvement were assessed by Hamilton depression rating ( HDRS) score at day 15, 30, 60 and 120 whereas biomarker alterations ( serum lipid profile- serum cholesterol, triglyceride, LDL-C, HDL-C and VLDL cholesterol) were assessed at day 30 and 120. Data were compiled and statistically analyzed using SPSS 20.0, student t-test and paired t – test. Results: Total 19 patients in Escitalopram group and 18 in Sertraline group had completed the study. The mean reduction in HDRS score were not statistically significant (p<0.05) between the groups whereas within the groups this reduction were significant (p<0.001). Amongst the lipid profile parameters, Sertraline showed a significant increase in serum cholesterol (p<0.001) as compared to Escitalopram. The rest of the lipid profile parameters were not increased significantly (p<0.05). Conclusion: Escitalopram and Sertraline have comparable efficacy in reducing the symptoms of depression in MDR-TB patients. Sertraline had significant effect on biomarker (serum cholesterol only) in comparison to Escitalopram.
| » CPO-7: Lack of Awareness of Pharmacovigilance among Young Health care Professionals: An Issue Urgently Needs to be addressed | | |
Singh J, Singh H, Kumar R, Gautam CS
Department of Pharmacology Government Medical College and Hospital, Chandigarh, India
E-mail: [email protected]
Objective: Young health care professionals (HCPs) are the pillar of a health care system. The objective of the present study was to assess the knowledge, attitude and practices of young HCPs regarding adverse drug reactions (ADRs) reporting. Methods: This cross–sectional questionnaire-based study was conducted on young HCPs in a tertiary care teaching hospital of North India. The study instrument was semi-structured, pre-validated questionnaire. The responses obtained were compared among doctors and nursing professionals. Results: We obtained response from 84 HCPs (61 doctors and 23 nurses). The mean age of the doctors and nurses was 25.0 ±2.4 vs. 26.3±3.4 years, respectively. No significant difference was observed in questions related to definition of ADR, components of pharmacovigilance, who can report ADRs and medications for which ADRs are to be reported. Only 9.8 % doctors and 26.1 % nurses were aware of ADR reporting system in India, of which 6 (26 %) nurses and none of the doctors were aware of its name. 16.4 % doctors as compared to 61% nurses admitted to have reported and ADR(p=<0.01). The main discouraging factor in ADR reporting were -time constraint among doctors while lack of knowledge was also highlighted by the HCPs. More nurses as compared to doctors (78.3 % vs. 49.2 %, P=0.01) were of the opinion that holding CME/workshop could encourage reporting. Conclusion: There is an urgent need to increase awareness about pharmacovigilance among young HCPs and adequate interventions should be instituted to encourage pharmacovigilance practices.
| » CPO-8: Efficacy and Safety of Olanzapine and Aprepitant Regimens in the treatment of Highly Emetogenic Chemotherapy Induced Nausea and Vomiting | | |
Prasad M, Chakraborty A, Shashidar V1
Departments of Pharmacology and 1Medical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: To evaluate the efficacy and safety of Olanzapine (OLN) and Aprepitant (APR) regimens in the prevention of highly emetogenic Chemotherapy Induced Nausea and Vomiting (CINV). Methods: The study was conducted in medical oncology department, VIMS & RC. It was conducted for a period of 6 months after the Institutional ethics committee approval, and taking informed consent. 50 participants were randomized into OPD regimen [Tab Olanzapine (10mg p.o), Inj. Palonosetron (0.25mg i.v.) and Inj. Dexamethasone (20mg i.v.) on Day 1; Tab Olanzapine (10mg p.o.) once daily for next 3 days] or APD regimen [Tab Aprepitant (125mg p.o.) Inj. Palonosetron (0.25mg i.v.) and Inj. Dexamethasone (12 mg i.v.) on day 1, Tab Aprepitant (80 mg p.o) and Tab Dexamethasone (8mg p.o) once daily on day 2 and 3; Tab Dexamethasone (8mg p.o.) once on day 4]. The efficacy was determined by Complete Response (CR) i.e. no nausea no vomiting at 24hrs (acute response), 72hrs (delayed response) and on 7th day post chemotherapy. Adverse drug reactions were graded. Statistical analysis was conducted by using SPSS software version 21. Results: CR was 81%, 84%, 76% for acute, delayed, and overall period in APD group. CR was 84%, 84%, and 72% for acute, delayed, and overall period respectively in OPD regimen. OLZ regimen was found to provide a better control in the overall period compared to APD one. (p<0.05; Chi square test). There were no significant grade 3 or 4 toxicities. Conclusion: Olanzapine regimen provides effective and safe control of CINV.
| » CPO-9: To Study the Efficacy of Ginger Extract (Zingiber officinale) in Pregnancy Induced Nausea and Vomiting | | |
Dass AP, Desai S1
Department of Pharmacology, GIMS, Kalaburagi, Karnataka, India,
E-mail: [email protected]
Background: Physiological signs of pregnancy such as nausea and vomiting are an indication of a good level of progestron supporting pregnancy but it is an unpleasant and discomforting symptom to deal with. Medications being a contraindication, especially during the first trimester of pregnancy,this study was undertaken to estimate the effects of a natural product for nausea and vomiting during pregnancy. Our study was directed to estimate the efficacy of ginger extract (Zingiber officinale) in pregnancy induced nausea and vomiting. Methods: 30 women who were 4-16 weeks pregnant, with symptoms of nausea and vomiting were included in this study (n=30). Subjects were given ginger extract 250mg, to be taken 3 times a day half an hour before food for 1 week. Severity of vomiting was assessed by Rhodes Index of Nausea and Vomiting by the patients. Baseline scores were compared with the score at the end of 7 day. The findings were analysed statistically. Results: Effect with the ginger extract in pregnancy induced nausea and vomiting was assessed at the end of treatment (day 7) and compared with the baseline values. Four patients reported symptoms of heartburn. Otherwise, there were no other reports of any adverse effects. The results showed statistical significance (p <0.005). Conclusions: Ginger extract (Zingiber officinale) helps in reducing severity and frequency of symptoms such as nausea and vomiting during pregnancy .Therefore, we conclude that natural remedies, like ginger extract can be used, for mild to moderate symptoms of nausea and vomiting induced by pregnancy, during first trimester.
| » CPO-10: Evaluation of Antidiabetic Activity of Hydro-alcoholic Extract of Syzygium Cumini Seeds in Alloxan Induced Diabetic Wistar Rats | | |
Quazi SH, Varma SK
Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India
E-mail: [email protected].
Objective: To evaluate the effect of Hydro-alcoholic extract of Syzygium cumini seeds (HESCs) in Alloxan induced diabetic Wistar rats. Methods: Albino Wistar rats of either sex were used for the study. Animals were divided into five groups of 6 animals each. Alloxan monohydrate was used to induce diabetes, dissolved in 0.9% sodium chloride in a dose of 150 mg/kg body weight. Group I was treated as- Control -Distilled water given, Group II - Diabetic control- alloxan (150 mg/kg body wt.) treated only once, Group III - Diabetic + HESCs 200 mg/kg body wt. extract treated, Group IV- Diabetic + HESCs 400 mg/kg body wt. extract treated, Group V- Standard - Diabetic + Glibenclamide (5 mg/kg body wt.). Study was conducted for a total of 28 days. In rats, random blood glucose levels were determined on day 0, 1, 3, 7, 14 and 28 days. The data was recorded and analyzed, by using ANOVA. Results: It was noted that the effect produced by different dosage (200, 400 mg/kg) of HESCs showed reduction in random blood sugar level and at dosage of 400mg/kg showed the significant reduction (P < 0.01) in random blood glucose level at the end of study when compared with the control. Conclusion: This experimental study indicates that HESCs possess anti-diabetic effects in Alloxan-induced diabetic rats.
Keywords: Alloxan, antidiabetic, hydroalcoholic extract, syzygium cumini
| » CPO-11: Statins Induced Myalgia and Myositis: Pain Severity and Impact on Daily Life Activities in Elderly Subjects | | |
Singh H, Chakrawarti A1, Guruprasad P2, Gupta YK2
Department of Pharmacology, Government Medical College and Hospital, Chandigarh, Departments of 1Geriatric Medicine and 2Pharmacology, All India Institute of Medical Sciences, New Delhi, India
E-mail: [email protected]
Objective: Statins associated muscle symptoms (SAMS) significantly affect daily life particularly in elderly users. Objective of the present study was to assess the severity of pain due to SAMS and the impact and interference of SAMS on routine activities of elderly statin users. Methods: In this cross sectional observational study, SAMS were evaluated in elderly subjects. Creatine Phosphokinase (CPK) levels were obtained for all patients. Brief pain inventory short form (BPI-SF) was used to calculate the Pain severity score (PSS) and Pain interference score (PIS). PSS and PIS were compared among statin users who developed myalgia with those who developed myositis. Results: 172 elderly statin users participated in the study. 38 statin users were to found to have SAMS, out of which 10 patients developed myalgia, 21 had myositis and 7 patients had only elevated CPK without myalgia. PSS and PIS were evaluated and compared in 31 patients who experienced myalgia or myositis. The mean PSS score was 5.4 ± 0.6.and mean PIS score was 3.17 ± 0.9. Elderly patients with myositis had significantly higher PSS and PIS score as compared to those with myalgia only (PSS, 5.6± 0.6 Vs. 5.1± 0.5, P=0.02 and PIS 3.4± 0.8 Vs. 2.6± 0.9, P=0.01). Conclusion: SAMS cause significant interference with routine activities and everyday life in elderly patients. Elderly statin users with myositis tend to have more pain severity and limitation in daily life activities as compared to those with myalgia, however, further research is warranted.
Keywords: Atorvastatin, creatine phosphokinase, myalgia, pain
| » CPO-12: Retrospective Analysis of Steven Johnson Syndrome and Toxic Epidermal Necrosis over a Period of 3 Years in a Tertiary Care Hospital, Jamnagar” | | |
Parmar NA, Jadav SP
Department of Pharmacology, M. P. Shah Government Medical College, Jamnagar, Gujarat, India
E-mail: [email protected]
Objectives: To study and detect the drugs commonly implicated in Steven Johnson Syndrome and Toxic Epidermal Necrosis in a tertiary care hospital, Jamnagar. Methods: A retrospective study was done in all patients who were admitted in last three years (January 2015- June 2017) in Jamnagar tertiary care hospital with the diagnosis of Steven Johnson Syndrome and Toxic Epidermal Necrosis. Results: A total of 13 patients with Stevens Johnson Syndrome and Toxic Epidermal Necrosis were studied. In 5 patients anti-microbial (ofloxacin, norfloxacin) was the causal drug , in 4 patients anti-epileptic (carbamazepine) was the causal drug and in rest patients analgesic (naproxen , aceclofenac) was the causal drug. Patients of Stevens Johnson Syndrome and Toxic Epidermal Necrosis induced by anti-epileptics were recovering fast compared to those induced by anti-microbials (ofloxacin and norfloxacin) and analgesics. Conclusion: Stevens Johnson Syndrome and Toxic Epidermal Necrosis induced by anti-microbials (ofloxacin and norfloxacin) has a higher morbidity and mortality compared to anti-epileptics and analgesics. Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects.
Keywords: Analgesic, anti-epileptics, anti-microbials, Steven Johnson syndrome, toxic epidermal necrosis
| » CPO-13: Study of Effects of Levothyroxine on Oxidative Stress Parameter and High Sensitivity C-reactive protein among Patients of Hypothyroidism Attending New Civil Hospital Surat | | |
Gohil NJ, Sinha AR
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
E-mail: [email protected]
Objective: Hypothyroidism is a common endocrine disorder which is treated with levothyroxine. Hypothyroidism is associated with premature atherosclerosis and cardiovascular disease. hsCRP is an independent risk factor for cardiovascular risk. Side effects commonly seen in patients taking levothyroxine for hypothyroidism. Oxidative stress might be the cause of the side effects. There are many researches regarding oxidative stress and hsCRP in hypothyroidism, but how levothyroxine therapy would affect oxidative stress and hsCRP in hypothyroid patients has not been researched adequately. The study was done to assess the impact of levothyroxine on hsCRP and oxidative stress as in previous studies there are conflicting results. Methods: This prospective observational study was conducted in 40 newly diagnosed hypothyroid patients. The individual participating in this study were compared for pre-treatment (baseline) and post-treatment (after 12 weeks) levels of oxidative stress and high sensitivity C-reactive protein. Results: Our results showed that after 12 weeks of levothyroxine therapy hsCRP level increased significantly as compared to before treatment. After 12 weeks of levothyroxine therapy Reduced glutathione (GSH – oxidative stress parameter) level increased which was statistically not significant as compared to before treatment level. Conclusion: Our finding suggest an association between levothyroxine treatment in hypothyroid patient and hsCRP but the association with oxidative stress is weak following levothyroxine treatment. Thus, hsCRP and possibly also oxidative stress could be additional risk factors contributing to increased cardiovascular risk following treatment with levothyroxine in hypothyroid patients.
| » CPO-14: Drug Utilization Study of Restricted Antibiotics in Intensive Care Units of Mcgann District Teaching Hospital, Shivamogga | | |
Hegde SV, Hanumaiah V, Revankar S, Prasad NS
Shivamogga Institute of Medical Science, Shivamogga, Karnataka, India
E-mail: [email protected]
Objectives: Drug utilization studies has very important value since it can help us to interpret, assess and improve prescribing patterns for diseases and ways to use medicine. The objective of the study was to assess the pattern of prescribing restricted antibiotics, also to evaluate their usage. Also to observe any adverse drug reaction related restricted antibiotics in ICUs. Materials and Methods: After taking approval from Institutional Ethics Committee study was undertaken over a period of 6 months. A prospective observational study was conducted to evaluate the prescription pattern on restricted antibiotic usage in ICUs. A standard case record Proforma was used to collect the cases in the ICU who were prescribed restricted antibiotics. Its indication, dose, frequency and duration were entered. Data was analysed by descriptive statistics. Results: A total of 200 cases who received antibiotics within 24 hours of admission in ICU were evaluated with mean age of 48.32. Average duration of stay in ICU was 4.18 days. Chronic obstructive pulmonary disease (30.2%), fever (16.3%), cardiovascular diseases (13.32%), Chronic renal conditions (9.4%) were commonly reported in ICU. Cephalosporins (96.7%) were commonly prescribed followed by Metranidazole (43.2%) and beta lactam antibiotics (9.6%). Number of antimicrobials prescribed per patient was 2.5. In only 20% of the cases culture sensitivity test was performed. Conclusion: Rational use of antimicrobials has to be encouraged in ICU. Polypharmacy and antibiotic use without culture report in ICU are major concern.
| » CPO-15: Knowledge-attitude-practice Survey Regarding High Alert Medication in a Teaching Hospital in Eastern India | | |
Chakraborty DS,Ghosh S, Das AK, Chatterjee S, Hazra A
Department of Pharmacology, Institute of Post-Graduate Medical Education and Research, Kolkata, West Bengal, India
E-mail: [email protected]
Background: Medication errors are a reality in all settings where medicines are prescribed, dispensed and used. High Alert Medications (HAM) are those that bear a heightened risk of causing significant patient harm when used in error. We conducted a knowledge-attitude-practice survey, among residents working in a teaching hospital, to assess the ground situation with regard to handling of HAM. Methods: We plan to approach 242 residents among the approximately 600 currently working in the hospital through purposive sampling. Residents in all disciplines (clinical, paraclinical and preclinical) are being targeted. A structured questionnaire that has been pretested on 5 volunteer residents is being used for data collection. The questionnaire is being administered to residents individually through face-to-face interview, by two raters, while they are on duty but not during rush hours. Results: Of the 56 residents approached so far, data from 50 have been analyzed, the rest having refused participation. Although background knowledge exists for majority of respondents, awareness levels regarding HAM are moderate and attitude is non-uniform. The number of respondents correctly able to identify most (> 80%) HAM in three common settings – intensive therapy unit, obstetrics and primary care are less than 70%. Several potential errors in practice have been identified. The study is ongoing. Conclusions: Situation requires corrective action. There is urgent need for improving awareness regarding HAM for the sake of patient safety. The pharmacology department can take the lead in designing awareness campaign with support from the hospital administration.
| » CPO-16: Comparative Evaluation of the Adverse Drug Reaction Profile of Olanzipine and Risperidone in the Patients Visiting Department of Psychiatry of a Tertiary Care Hospital in Central India | | |
Ayesha A, Varma SK, Nanotkar S
Departmemt of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India
E-mail: [email protected]
Objective: Comparative evaluation of Adverse Drug Reactions (ADR) due to Olanzapine and Risperidone in the subjects visiting Dept. of Psychiatry of a tertiary care hospital in central India. Methods: It is an observational, prospective, non-interventional, longitudinal study conducted in the psychiatric unit of a tertiary care hospital. Study duration was from January 2012 to may 2013. Patients on olanzapine & risperidone drug from psychiatry Department were considered for study with 100 subjects in each group. Statistical analysis was done using ANOVA. Results: Among the 200 patients, in the Risperidone group, reported ADRs were 180 whereas in the Olanzapine group were 218. Most of the ADRs were reported from Central Nervous System in both the groups. Sedation was the most commonly cited complaint with the incidence of 31.8% in the Risperidone group and 40.2% in the Olanzapine group. Extrapyramidal symptoms (11.4%) were found to be more in the Risperidone group, whereas Olanzapine demonstrated higher incidence of Mood changes (25.0%). the incidence of Anticholinergic adverse effects was found to be comparable in both groups. Majority of the adverse effects were assigned POSSIBLE after causality analysis and MILD after severity assessment in both the groups. Conclusion: We conclude that both Risperidone and olanzapine have propensity to cause potential systemic ADRs with deleterious changes in various metabolic parameters. Having watch over the ADRs profile of these drugs, we can definitely safeguard the health of the user population.
Keywords: Adverse drug reaction, olanzapine, risperidone
| » CPO-17: To Study the Impact of Socio-demographic Parameters and Utilization Pattern of Antimicrobials in UTI during Pregnancy. An Observational Study | | |
Vyas A, Tandi GP, Batar KK, Rathore RK, Gehlot A
Department of Pharmacology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India
E-mail: [email protected]
Objective: This study was conducted to evaluate impact of socio- demographic parameters and utilization pattern of antimicrobials during pregnancy. Methods: Two hundred suspected symptomatic cases of UTI were included in our study. Out of 200 cases, 100 cases were positive for urine culture and sensitivity. After institutional ethics committee approval, informed consent was taken from eligible participants. Isolated microbes were tested for antimicrobial susceptibility testing by the standard Kirby Bauer's disc diffusion method. Various demographic parameters included distribution of UTI in relation to gestational age, parity, age of pregnant women, socio economic status, education level etc. Results were analyzed by appropriate statistical tests using spss17.0. Results: Out of the 200 urine samples examined, 100 were found to contain significant bacteruria. Overall incidence of UTI in pregnant women was found to be 50%. We found significant growth of E.coli, S.aureus, enterococci, klebsiella and S.saprophyticus. These represented 56%, 15%, 11%, 8% and 5% of isolates respectively. The sensitivity pattern of gram negative isolates showed that most of isolates were sensitive to linezolid (96.15%), imepenam (96.15%), ofloxacin (89.74%) and amikacin (78.20%). We observed increasing resistant pattern for gram negative isolates to cefixime and augmentin (65.39%), ampicillin (58.98%) and cefoperazone (48.72%), respectively. Multipara women had an increased risk (40%). The frequency was higher in third trimester (42%).In our study 84% women had past history of UTI. Lastly, average drugs per prescription was 3.26, this is higher than WHO range of 2 or less. Polypharmacy in some instances becomes necessary especially when the patient has some comorbid conditions associated with the pregnancy. Conclusion: Various socio- demographic parameters affect the utilization pattern. Overall incidence of UTI in pregnant women was found to be 50% due to lower socioeconomic status, poor hygiene, & low level of education at our region.
| » CPO-18: Impact of Vitamin D3 Supplementation on Glycemic Control in Type 2 Diabetes Mellitus at Tertiary Care Hospital | | |
Banzal N, Desai A
Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
E-mail: [email protected]
Objective: To determine the effect of vitamin D3 supplementation on glycemic control in Type 2 diabetes mellitus. Materials and Methods: This was an observational study, patients diagnosed with confirmed type II diabetes mellitus for more than six months were included. According to level of Vitamin D3 patients were classified in two groups as Vitamin D3 deficient group (<30 ng/ml) and Vitamin D3 sufficient group (≥ 30 ng/ml). Deficient group was supplemented with vitamin D3. Laboratory investigations like FBS, PPBS, HbA1c & serum vitamin D3 were carried out at the beginning (pre-treatment) and after a gap of 3 months (post-treatment). Observations and Results: In the study, the group 1 patients mean value of vitamin D3 before treatment was 17.3±5.9 ng/ml. Post treatment with Vitamin D3 mean value was 30.7±12.3 ng/ml (p<0.001). The pre treatment HbA1c mean values were 8.5 ± 2.5% and post treatment the values were 7.6 ±1.9% (p = 0.005). The pre treatment FBS mean values were 146±39 mg/dl and post treatment the values were 139.5 ± 42.9 mg/dl (p = 0.007). The pre treatment PPBS mean values were 207.4 ± 68 mg/dl and post treatment the values were 177 ± 61.3 mg/dl (p = 0.007). Conclusions: On the basis of our study, we observed that those having vitamin D3 deficiency are likely to have an early onset of diabetes mellitus and we found a positive association between vitamin D3 status and glycemic control in type 2 diabetes mellitus patients.
Keywords: Glycemic control, HbA1, type 2 diabetes mellitus, Vitamin D3
| » CPO-19: To Analyse Cost of Patient Care and Drug Utilization in a Paediatric Intensive Care Unit at a Tertiary Care Hospital in India | | |
Dhiman AS, Munshi RP, Bavdekar S, Taur S
Topiwala National Medical College, B. Y. L. Nair Charitable Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To assess diagnosis based cost of patient care at a Paediatric Intensive Care Unit (PICU) and drug utilization of antibiotics. Methods: We carried out a study to analyse diagnosis-based costs of paediatric patient care at a PICU at a tertiary care hospital in Mumbai on the basis of identified cost components- Direct: fixed and variable, and Indirect. Results: Out of 167 patients enrolled, 61% were boys, 39% were 1-7 months old with an average of 4 bed days. Cost of direct fixed components (salaries, capital equipment, disposables) was calculated to be Rs.64, 48,200/six months. The maximum cost of direct variable components spent by the hospital (physiotherapy intervention, expert opinion, investigations, medicines, blood products, piped gases) was Rs.548.63/patient/day for treatment of non-infectious diseases. Cost of indirect components (building maintenance) was calculated to be Rs. 12,500/six months. 97.4% and 79% of the total 584 prescriptions were prescribed by their generic names and were available at the hospital pharmacy. 78.44% patients were prescribed with ≥1 antibiotic/s with an average of 2±1.27 antibiotics/ prescription. 62.8% patients were prescribed third generation cephalosporins. The prescribed daily doses of all antibiotics except ceftriaxone were in limits of predetermined standard defined daily dose. Conclusion: Conclusion: In this study the treatment cost varied drastically as per respective diagnosis and the costs would further vary as per the size of ICUs in different healthcare settings. There is a need for development of ICU costing methodologies which would help in better allocation of resources and deployment of personnel.
| » CPO-20: A Pharmacokinetics Study to Validate the Concentration of Prophylactic Ceftriaxone in Tissue and Serum in Laparoscopic Cholecystectomy Surgery | | |
Malik Kumar Neeraj, Varma Veena
Department of Pharmacology, VMMC and Safdarjung Hospital, GGSIPU, New Delhi, India
E-mail: [email protected]
Objective: 1. To determine the concentration of prophylactic ceftriaxone in tissue and serum at the time of incision, during surgery and closure in laparoscopic cholecystectomy surgery.2. To conclude whether levels determined are above minimum inhibitory concentration (MIC). Methods: Serum drug levels and soft tissue drug levels estimated in high performance liquid chromatography (HPLC) with a reverse phase technique. Results: Mean concentration of ceftriaxone in sample at the time of incision was found to be 10.6 mg/l and 6.9mg /l at the time of closure in tissue. Mean concentration of ceftriaxone in serum during incision and closure is 175.3mg/l and 125.8 mg/l respectively. The mean of tissue level of ceftriaxone at surgical plane is 17.3mg/l and mean of serum is 153.6mg/l. Conclusion: The serum as well as tissue samples were found to be above 4 times the MIC value of organisms implicated for surgical site infections of ceftriaxone in laparoscopic cholecystectomy surgery which is well above as per CLSI guidelines.
| » CPO-21: Correlating Study of Amoebic and Pyogenic Liver Abscesses with Respect to Age and Mode of Presentation | | |
Mrutyunjay M
Department of Pharmacology, Gadag Institute of Medical Sciences, Mallasamudra, Gadag, Karnataka, India
E-mail: [email protected]
Aims and Objective: To study clinical presentation of amoebic and pyogenic liver abscesses with respect to age and mode of presentations. Materials and Methods: A detailed history was taken from each of these patients and all of them were subjected to a through clinical examination. These patients were then subjected to investigations available within the hospital such as Hb, Total Count, ESR, RBS, Blood Urea, Serum creatinine, liver function tests(SGOT ,SGPT, Serum bilirubin, ALP, Serum albumin, Total proteins, A:G ratio, PT and INR).Ultrasonography of abdomen was done in all cases. Pus was sent for gram's stain and culture and sensitivity. Results and Conclusion: The highest incidence occurred in the age group 31-50 yrs, Fever and pain abdomen were the most consistently occurring symptoms. AIl the patients with liver abscess had abdominal tenderness.
| » CPO-23 | | |
Plasma Olanzapine Concentration: Relation with Dose, Adherence to Medication, and Clinical Efficacy
Sontakke SD1,2, Ingale NS1,2, Turankar AV1,2, Motghare VM1,2, Saoji AM3,2
1Department of Pharmacology, Government Medical College, 3Department of Psychiatry, Indira Gandhi Government Medical College, Nagpur, 2Maharashtra University of Health Sciences, Nashik, Maharashtra, India
E-mail: [email protected]
Objective: To estimate plasma olanzapine concentration (POC) using liquid chromatography-mass spectrometry (LCMS) and identify factors that contribute to pharmacokinetic variability of olanzapine. Methods: Prospective, observational study initiated after approval of institutional ethics committee. Stable patients of schizophrenia on olanzapine, above 18 years of age, either gender, on olanzapine therapy for at least 12 weeks with no change in dose for at least one week were included. Plasma levels of olanzapine were assessed using HPLC based kit on LCMS. To assess response to treatment patients were subjected to Brief Psychiatric Rating Scale (BPRS) in which lower score indicates better response. Adherence to therapy was assessed by using Morisky 8-Item Medication Adherence Questionnaire in which lower score indicates better adherence. Graph pad prism version 6.0 was used for statistical analysis. Results: POC was higher in women compared to men. No correlation was observed between POC and age(r = 0.01343, p= 0.9470) or daily dose of olanzapine (r= -0.2765, P = 0.1626). Patients having POC more than 20 ng/ml had better adherence (Morisky's score 1 or 2) to medication compared to those having POC less than 20 ng/ml. Significant correlation was observed between POC and clinical response(r = -0.4371, p=0.0226). Conclusion: TDM of olanzapine is important considering large interpatient variability in POCs at same dosages. It also helps in improving efficacy, particularly when patients do not respond to therapeutic doses or when they develop adverse effects. Cost of procedure is major concern which needs to be considered before this can be established in routine practice.
| » CPO-24: Drug Utilization Study in Geriatric Patients Attending Outpatient Departments of Tertiary Care Teaching Institute in Central India | | |
Khamkar AD1,2, Motghare VM3,2, Gawade SJ3,2
1Department of Pharmacology, Lokmanya Tilak Municipal General Hospital and Medical College, Mumbai, 2Maharashtra University of Health Sciences, Nashik, 3Department of Pharmacology, Government Medical College and Hospital, Nagpur, Maharashtra, India
E-mail: [email protected]
Objectives: To study trends in drug prescription in geriatric patients attending the outpatient departments (OPDs) of the tertiary care teaching institute. To calculate the defined daily dose (DDD) of commonly used drugs. To calculate percentage of drugs prescribed included in the National essential medicine list. To evaluate the use of potentially inappropriate medications in elderly according to Beers 2012 criteria according to AMERICAN GERIATRIC SOCIETY. Methods: This was a cross-sectional, observational study initiated after approval of Institutional Ethics Committee in Tertiary care teaching institute in central India. 1000 patients, of either gender, aged 65 years or more from the outpatient departments were included. Analysis of prescriptions and calculation of DDD usage of commonly prescribed drugs was done. Beers 2012 criteria was used to identify potential inappropriate medications for elderly patients from the prescriptions. Results: Drugs involving cardiovascular system were most frequently prescribed drugs followed by gastrointestinal system. Ranitidine 150 mg was most frequently prescribed drug followed by Aspirin 75 mg. Out of total 5015 drugs prescribed, 506 (10.08%) were FDCs and 4509 (89.9%) contained only one ingredient. Oral route was the most common route of drug administration (4523; 90.1%). 91% were prescribed by generic name. 4440 (88.53%) drugs prescribed were from NLEM 2011. Conclusion: Irrational prescribing and polypharmacy are prevalent among elderly. Gerontopharmacological education is needed to be inculcated among medical students. Drug utilization studies of this type may ultimately help in improving the quality of healthcare given to the geriatric patients
| » CPO-25: A Study of Antimicrobial Use in Children Admitted to Pediatric Intensive Care Unitof a Tertiary Care Hospital | | |
Mishra K, Hazra A, Sarkar S
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
E-mail: [email protected]
Objectives: Inappropriate antimicrobial use in tertiary care hospitals is a matter of increasing concern. We conducted an observational study on children admitted to the PICU of a teaching hospital in Eastern India, to generate a profile of antimicrobial use and suspected adverse drug reactions (ADRs). Methods: Children of either sex, aged between 1 month to 12 years, were studied. Baseline demographic and clinical features, duration of hospital stay, antimicrobials received, dosing, indications and details of ADRs were recorded. Every patient was followed up till discharge or death. Surgical and burn cases were excluded. Results: Till date 105 admissions, fulfilling eligibility criteria, have been screened. Prevalence of antimicrobial use is 100%. Majority were boys (61.10%) and from rural and low socioeconomic background. Median age was 36 months. 10 children died and rest discharged. Mostly multiple (63.4%) antibiotics were used. Beta- lactams, aminoglycosides, quinolones, macrolides ,Glycopeptides, antivirals, antimalarials and antituberculars & antiprotozoals were used. Average number of antimicrobials per patient was 4.0 ± 1.27; majority (94.1%) were by parenteral route and initial choice was usually empirical. Prescriptions written in generic name. Treatment ranged between 2 – 45 days, with median of 7 days. Six ADRs were noted of which half were skin rash and rest loose stools & renal insults. Conclusions: The profile of antimicrobial use is similar to earlier studies. Overuse of multiple antimicrobials per prescription and parenteral route requires exploration. Antimicrobials are used empirically in absence of policy. The baseline data can serve in situation analysis for antibiotic prescribing guideline.
| » CPO-26: Survey of Residents and Nurses on Similar Sounding or Looking Medicines in a Tertiary Care Teaching Hospital | | |
Ray S, Mishra K, Hazra A, Chatterjee S
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
E-mail: [email protected]
Objective: Medication errors are the reality in all settings where medicines are prescribed, delivered and used. Presence of different medicines with similar sounding names and different pharmaceutical products with similar packaging or labeling (sound alike look alike [SALA] medication) increases the risk of errors with potentially serious consequences . We are conducting a survey among residents and nursing personnels to estimate the prevalence of this problem regarding SALA medication. Methods: We plan to approach 320 of residents and nurses among approximately 1800 currently working in the hospital through purposive sampling. Residents in all disciplines (clinical, paraclinical and preclinical) are being surveyed. A structured questionnaire that has been pretested on 5 volunteer residents is used for data collection. The questionnaire is being administered to respondents individually through face-to-face interview. Results: Of 87 respondents approached so far, data from 80 have been analyzed, the rest having refused participation. Although background knowledge exists for majority of residents and nurses, a large proportion is not aware of the SALA term. However, knowledge about the consequences of confusing names and looks increase risk of errors when evaluating with SALA problem. Estimated prevalence of errors , relates to 30% of respondents. The study is ongoing. Conclusions: There is urgent need for improving awareness regarding SALA medication for the sake of patient safety. The pharmacology department has a role to play in this regard with support from hospital administration.
| » CPO-27: Adverse Drug Reaction Profile at Radiotherapy, Paediatrics and Ear, Nose and Throat Department of a Tertiary Care Teaching Hospital: Descriptive Cross Sectional Study | | |
Raghute LB1,2, Dr. Dakhale GN3,2, Kalikar MV3,2, Pamarthi AS3,2
1Department of Pharmacology, Government Medical College, Gondia, 2Maharashtra University of Health Sciences, Nashik, 3Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India
E-mail: [email protected]
Objective: To do surveillance of ADRs in outpatient department (OPD) and wards of radiotherapy, paediatrics and ENT department of a tertiary care teaching hospital.
To classify adverse drug reactions (ADRs) as per type, severity, system involvement, pharmacological group of causative drug. To study ADRs according to their demographic distribution. To do causality analysis of ADRs. Materials and Methods: This was a descriptive cross sectional study carried out for detection, classification, assessment and causality analysis of ADRs. Study was conducted in patients attending OPD and admitted in wards of radiotherapy, paediatrics and ENT department of tertiary care teaching institute after approval from Institutional Ethics Committee. Study period was from 01.12.14 to 31.09.16. Suspected ADRs were analyzed using Naranjo's scale and documented. Results: Maximum ADRs were seen with radiotherapy (84.90%), ENT (10.74%) and paediatrics (04.36 %) department. Definite relationship was established between drugs and ADR in 01 (0.33%) patient, while 247 (82.89%) and 50 (16.78%) ADRs were categorized as probable and possible respectively. Maximum patients were reported in moderate group i.e. 166 (55.70%) and mild group included 128 (42.95%) patients. Four (01.34%) patients were labelled as suffering from severe ADRs. Conclusion: Maximum ADRs were from Radiotherapy department due to platinum compounds followed by ENT department due to antibiotics and antihistaminics followed by paediatrics department where ADRs were commonly due to antibiotics. Maximum ADRs were observed in age group 41 – 60 years and were more in females.
| » CPO-28: Development and Validation of an Analytic Method using High Performance Thin Layer Chromatography to Determine Serum Zonisamide Levels and its Application in Therapeutic Drug Monitoring | | |
Gawde NR, Munshi RP
Department of Clinical Pharmacology, TNMC and BYL Nair Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Zonisamide is a novel and effective medication used in anti-epileptic drug therapy to optimize and control recurrent seizures. Therapeutic drug monitoring aids in monitoring the drug therapy. Although there are various methods available for monitoring of Zonisamide drug level, these methods are expensive. Hence we have developed and validated a HPTLC method for the quantitative determination of serum Zonisamide level. The chromatographic separation was carried out on silica gel 60F254 plate using a mixture of Ethyl acetate: methanol: toluene (4: 1: 5) as mobile phase. Densitometric detection was carried out at 254nm. The method was validated for Linearity, Precision, Selectivity, Limit of Detection and Limit of Quantification and Accuracy. Linear calibration curves in the range of 5 to 80μg/band gave correlation coefficient of 0.991. The intra-day (n=6) and inter-day (n=18) precision, expressed as the relative standard deviation were in the range of 2.83% to 3.27% and from 2.09% to 4.39%. The limit of detection and the limit of quantification were found to be 1.07μg/band and 3.15μg/band. The accuracy was calculated as percentage recovery and was found to be 97.52% and 115.23%. Theophylline was used as an internal standard, which gave a well separated peak at Rf 0.36 showing no interference with Zonisamide. Thus the method was specific with no matrix interference. Thus, the method developed for the estimation of serum Zonisamide level is simple, cost-effective and reliable for therapeutic drug monitoring.
| » CPO-29: To Evaluate the Self Medication Pattern among Geriatric Patients through Home Medication Review | | |
Mangla R, Mangla N
Department of Pharmacology, PGIMS, Rohtak, Haryana, India
E-mail: [email protected]
Introduction: Elderly population is more likely to self-medicate due to lack of accessibility to health care services. Home medication review is a comprehensive study which provides a physician an opportunity to visit an elder in the familiar surroundings of the latter's home. It brings health care provider to get a closer look into the community and to look into the unmet needs of the geriatric population. Materials and Methods: This study was undertaken to evaluate prevalence and pattern of use of self-medication among elderly individuals. A total of 70 elderly were interviewed by door to door survey in an area of 4 sq. km. surrounding PGIMS, Rohtak. Questionnaire regarding self-medication was utilized for interview. Results: Out of 70 elderly included in study, 47(67.1%) reported self-medication in 3-month recall period. About 60% were male and mean age was 67±4.21 (60-85) years. Constipation (21.43%) was the most common disease for self medication. Lactulose (15%), ispaghula husk(6%), paracetamol(4%) were most frequently used for self medication followed by home remedies and ayurvedic medicines. Most common reasons for self medication were convenience (86%) and cost (14%). Conclusion: Self medication is highly prevalent among geriatric population. Home medication review bridges the communication gap between the physician and geriatric population, as latter are more prone to self medication given their lack of unawareness and chronic intake of multiple medicines for various co-morbid conditions.
| » CPO-30: Response Rate of Relapsed and Refractory Multiple Myeloma Treated with Thalidomide Therapy: A meta-analysis | | |
Vardhan G, Handu SS, Dhamija P
Department of Pharmacology, All India Institute of Medical Science, Rishikesh, Uttrakhand, India
E-mail: [email protected]
Objective: To determine the proportion of response rate (CR/PR) for patients with relapsed and refractory multiple myeloma treated with thalidomide therapy. Methods: Literature was searched using MEDLINE, PubMed, EMBASE, Trip Database, Cochrane library and clinicaltrial.gov to identify studies on refractory multiple myeloma treated with thalidomide therapy till 11 November, 2017. Data was extracted independently by two reviewers. Clinical trials which studied with thalidomide for relapsed and refractory MM were which reported the data of response rate (CR/PR) included in the proportional meta-analysis. STATA version 13.0 software was used for conducting the proportional meta-analysis. Results: 12 studies consisting of 635 patients were included in the present meta-analysis. Pooled analysis observed that response rate of thalidomide therapy was 51% with 95% confidence interval 48% to 55%. Conclusion: The present meta-analysis suggests that satisfactory response rate for the patients with relapsed and refractory multiple myeloma undergoing the thalidomide therapy.
| » CPO-31: Comparative Study among Three Doses of Oral Midazolam Syrup as Premedication in Children Undergoing General Anaesthesia for Lower Abdominal Surgeries | | |
Dadhich J, Dadheech R, Bhargava J, Dhaka M
Department of Pharmacology, S.M.S. Medical College, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
E-mail: [email protected]
Objective: Adequate premedication in children can allay their anxiety and facilitate their separation from parents. Recent studies have shown that Midazolam given orally is as effective as given by nasal route. Because of its unique structure the bioavailability of oral Midazolam depends on the pH of the solution. This study showed effects of three different doses of oral Midazolam as premedication in children undergoing General Anaesthesia (GA) for lower abdominal surgeries. Methods: 60 patients, between age 1 and 5 years, of either sex planned for lower abdominal surgery, were randomly allocated to three groups, Group A, Group B and Group C, receiving Midazolam syrup in a dose of 0.5mg/kg, 0.75 mg/kg and 1 mg/kg respectively 30 minutes prior to surgery. The patients were then assessed for Reaction to Parent separation, Sedation score, Ease of induction of GA and Time to spontaneous eye opening. Results: In the Group A 50% (10/20) patients complained on parent separation and 30% (6/20) patients had poor acceptance of GA whereas the Sedation score was higher in 55% (11/20) patients of Group C. 70% of patients (14/20) in Group B were quiet but awake on parent separation and 85% (17/20) patients accepted GA easily. There was no difference among the groups with regard to time to spontaneous eye opening. Conclusion: Oral Midazolam premedication given in a dose of 0.75mg/kg allays anxiety and reduces the trauma of parent separation without causing excessive sedation in children.
| » CPO-32: Preventability, Predictability, Severity and Causality Assessment of Adverse Drug Reactions Reported from Teaching Hospital in Chhattisgarh | | |
Keche YN, Gaikwad NR, Bandyopadhyay A, Dhaneria SP
Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
E-mail: [email protected]
Objective: To assess the preventability, predictability and severity of Adverse Drug Reactions (ADRs) using different assessment scales. Methods: ADR Monitoring Center under newly established teaching hospital in Chhattisgarh collected ADR reports from different healthcare professionals during period of November 2016 to November 2017. Analysis of reported ADRs was done for their causality assessment, demographic details of patients, most common drug/drug class responsible for ADR. Seriousness and preventability of ADRs was analysed by using WHO causality scale and Schumock and Thornton scale respectively. Severity of ADRs was assessed by Hartwig and Siegel scale. Results: A total of 86 ADRs were reported during this one-year period .Of 86 ADRs, 9(10.47%) were serious ADRs. The categorization of ADRs based on causality assessment showed 1.16% certain, 58.15% probable, 39.53% possible & 1.16% unlikely ADRs. Serious ADRs were caused by mefenamic acid plus paracetamol combination and zoledronic acid. The highest number (23.26%) of ADRs were reported to antimicrobials, out of which 6.97% were causally related with antituberculosis therapy and 3.49% were related with amoxicillin plus clavulanic acid combination. As per Schumock and Thornton scale, 80.23% ADRs were not preventable, 12.79% and 6.98% were definitely and probably preventable respectively. Conclusion: More number of ADRs were observed with antimicrobials. As many ADRs in this study are non-serious and not preventable, management of such ADRs through therapeutic interventions would be beneficial in better patient outcome. In addition to causality assessment, ADRs shall also be analysed for preventability and severity assessment for better patient care. Strengthening of Pharmacovigilance activities will increase ADR reporting that will contribute in national database for safe use of the drugs.
| » CPO-33: Pharmaco-epidemiology of Drugs Used in Post-cataract Surgery Patients in Tertiary Care Hospital | | |
Hiremath Geetanjali, Masare Pankajkumar, Kotinatot Basavaraj
Department of Pharmacology, Belagavi Institute of Medical Sciences, Belagavi, Karnataka, India
E-mail: [email protected]
Introduction: Pharmaco-epidemiology is the application of epidemiological knowledge, methods, measurements, analysis and reasoning to study uses, cost effectiveness and adverse effect of drugs in defined population. Objectives: To understand and evaluate the drug utilization pattern in post cataract surgery patients at the department of ophthalmology, BIMS Belagavi. Materials and Methods: This study was conducted in department of ophthalmology BIMS belagavi. A total of 449 patients' prescription was analyzed prospectively. The data was collected in a proforma containing relevant demographic and study details. The data was analyzed statistically and results were expressed as numbers and percentage. Results: A total of 449 patients were analyzed. Among these 63.92% were female and 36.08% were male. The total number of drugs prescribed was 2306. All patients received topical eye drops includes bromfenac 0.1% eye drop and other one is a fixed drug combination of Dexamathasone 0.1% plus Ofloxacin 0.3% eye drop. Use of antibiotic in association with sex found to be significant (p- value <0.004). Average number of drugs per prescription was 5.1 and drugs which prescribed in generic name were 60.99% and 38.94% were prescribed by brand names. Fixed drug combination includes 19.50% and drugs from essential drug list used were 80.49%. Conclusion: To conclude, fluoroquinolines and corticosteroids were the most frequently prescribed drug groups in post cataract surgery patients. Rational prescribing is an important criterion for convenience of a patient in terms of disease, adverse events and treatment cost.
| » CPO-34: Comparative Study of Efficacy of Preoperative use of Nepafenac 0.1% Versus Flurbiprofen 0.03% in Maintenance of Intraoperative Mydriasis for Cataract Surgery: A Randomized Double Blind Study | | |
Manjunath H, Hanumaiah V, Kumar PM
Department of Pharmacology, Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, India
E-mail: [email protected]
Objective: To compare the efficacy and safety of preoperative use of Nepafenac 0.1% versus Flurbiprofen 0.03% in maintenance of intraoperative mydriasis for SICS. Methods: This prospective, randomized, double blind comparative study was conducted on adult patients diagnosed with cataract and posted for SICS with Nepafenac 0.1% as the test drug and Flurbiproen 0.03% as the control drug. Both horizontal and vertical pupil diameter was measured by the ophthalmologist before sclerocorneal incision and at the end of surgery. Data was analysed with descriptive statistics. Demographic data was compared with chi-squared test and outcome was analysed with Mann Whitney U test. P value < 0.05 was considered as significant. Results: Total of N=100 patients was operated for cataract surgery. But 95 patients (Nepafenac 0.1% n= 48 and Flurbiprofen 0.03% n = 47) were analysed. Female patients were more in both the groups constituting 68.15% and 70.2% for Nepafenac and Flurbiprofen group respectively. Mean age was 62.91±10.31 in Nepafenac group and 62.98 in Flurbiprofen group. There was no significant difference for horizontal (p 0.527) and vertical (p 0.331) pupil diameter between groups before sclerocorneal incision. There was statistical significant difference for horizontal (p<0.001 with mean rank of 61.85 for Nepafenac and 33.85 Flurbiprofen group) and vertical (p <0.001 with mean rank of 63.88 for Nepafenac and 31.37 for Flurbiprofen group) pupil diameter at the end of surgery between groups. Conclusion: Nepafenac 0.1% is superior in maintatenance of intraoperative mydriasis and than Flurbiprofen 0.03%.
| » CPO-35: Comparison of Antihypertensive Effect of Azilsartan with Telmisartan in Diabetic Patients - An Observational Study | | |
Vaid R, Dange SV
Department of Pharmacology, Dr. D.Y. Patil Medical College, Pune, Maharashtra, India
E-mail: [email protected]
Introduction: Despite the availability of effective drugs for hypertension, it remains uncontrolled in majority of patients. Azilsartan, a new antihypertensive drug, has not been studied in diabetic hypertensives. Objective: To study the efficacy of azilsartan in patients of T2DM & HT and compare that with telmisartan. Methods: Adult patients attending the OPD of Dhanashree Hospital, New Sangavi, Pune; suffering from T2DM and HT were studied. They were treated with usual oral anti-diabetic drugs and received either telmisartan 40mg/d or azilsartan 40 mg/d for hypertension. Clinical examination and laboratory parameters were assessed every three months over a period of six months. Data obtained were analysed by Student´s t-test and P value < 0.05 was considered as statistically significant. Results: Seventy-one patients were enrolled in the study. Nine were lost during follow-up. Thirty two patients received telmisartan, while 30 were treated with azilsartan. Both the groups were comparable at base-line with respect to clinical & laboratory parameters. Both drugs significantly reduced SBP (152+/-23 vs136 ± 14 mm Hg) and DBP (158+/-25 vs. 127 ± 12 mm Hg). Azilsartan was significantly (P<0.05) more effective in reducing the blood pressure than telmisartan. There was no significant difference in the glycaemic and lipid parameters. Both drugs were well tolerated. Conclusion: Azilsartan was significantly more effective than telmisartan as an antihypertensive in T2DM patients.
Keywords: Azilsartan, hypertension, T2DM, telmisartan
| » CPO-36: Study of Transfusion Related Adverse Events at a Tertiary Care Centre: A Regional Haemovigilance Retrospective Study | | |
Saiyadali A, Dheemantha P, Jayanthi CR, Narayana Reddy S
Departments of Pharmacology and Immuno-haematology and Blood Transfusion, Bangalore Medical College and Research Institute, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objective: To analyze the adverse transfusion reactions (ATRs) according to haemovigilance as a part of Pharmacovigilance Program of India (PvPI) in our institution. Methods: A retrospective review of all ATRs reported to the department of Immuno haematology and blood transfusion, Victoria hospital attached to BMC&RI, Bengaluru between December 2012 and November 2017 was done. All the reactions were reported in a pre-designed Transfusion reaction reporting form for blood and blood products as per the Haemovigilance, PvPI. Transfusion reaction work-up was done in each transfusion reaction. Pattern of ATRs were analyzed for age, gender, types of blood products and ATRs. Distribution of ATRs year wise over a period of 5 years was assessed. Results: Total blood components issued by our blood bank to various departments and total ATRs during the study period were 48,576 and 89 respectively. ATRs were experienced by all age groups with a male preponderance (56.18% males). Majority of the reactions occurred with whole blood (0.46%) followed by packed red cells (0.19%). The commonest ATR observed was febrile non haemolytic transfusion reaction (88.76%) followed by anaphylaxis (2.25%). Most of the ATRs were acute reactions, transfusion siderosis being the only delayed reaction. Conclusion: Majority of ATRs were due to whole blood transfusions. Underestimation of true incidence because of underreporting which can be improved by strengthening of hemovigilance system.
Keywords: Adverse transfusion reaction, blood transfusion, haemovigilance
| » CPO-37: Perception and Acceptance of Generic Medicines among Local Medical Practitioners in Mumbai City: A Questionnaire-based Cross-sectional Study | | |
Paul KB, Belhekar MN, Pandit PR, Bhave KA, Patel TC, Mundada KV
Department of Pharmacology, Hinduhrudaysamrat Balasaheb Thackarey Medical College and Dr. Rustom Narsi Cooper Municipal General Hospital, Bhaktivedanta Swami Marg, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To assess knowledge, attitude and perception of local medical practitioners regarding generic medicines in Mumbai. Methods: A prospective, cross-sectional study was conducted with 80 local medical practitioners in Mumbai using a pre-validated questionnaire consisting of 34 questions on the knowledge, attitude and perceptions about generic drugs. Data was analysed for number and percentage. Results: All the 80 participants responded to the questionnaire (100%). Of them, 57 (71%) prescribed generic medicines. The participants were aware of the term 'generics' (56, 70%), 'generic name' nomenclature (41, 51%), and approvals required for manufacturing generic medicines (63, 79%). Twenty-six (33%) participants felt that generic drugs are equally efficacious and safe as compared to branded drugs, compared to 17 (21%) who felt that they are safe but less efficacious. About half of the participants felt that switching to generics would not affect the outcome of the therapy (42, 53%). A majority believed that prescribing generic medicines would decrease the overall cost of health expenditure (67, 84%). Fifty-one (64%) participants agreed that the recently revamped Jan Aushadhi campaign will be successful in creating a demand for generic drugs and 22 (28%) said that this is very much needed in our country. Cost-effectiveness (46, 58%) is the main reason for prescribing generic medicines; whereas unavailability (44, 55%) and lack of encouragement by physicians (42, 53%) are the major reasons against generic medicines. Conclusion: This study shows that practising doctors have good awareness about generic medicines and the Jan Aushadhi scheme. However, concerns about their availability and lack of encouragement by physicians are the major reasons for not preferring generic medicines.
| » CPO-38: A Prospective Study to Assess the Effect of Intravenous Subhypnotic Doses of Midazolam during Spinal Anesthesia for Cesarean Section | | |
Lalitha A, Mamatha KR, Prabha P1
Department of Pharmacology and Anesthesia, Bangalore Medical College and Research Institute, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objective: To evaluate the effect of intravenous subhypnotic doses of midazolam during spinal anaesthesia for caesarean delivery. Methods: An open label placebo controlled study was conducted by recruiting 60 parturients aged 20-30 years with ASA class I and II undergoing spinal anesthesia for cesarean section. One group (n=30) received midazolam 0.02 mg/kg bolus immediately after delivery of baby and 0.01mg/kg half hourly. Control group (n=30) received normal saline as placebo. Hemodynamics was monitored at 3-minute intervals. Visual analog scale was used to evaluate intraoperative emetic episodes. Sedation was assessed by Ramsey sedation scoring. Mephentermine consumption was also recorded. Results: The incidence of nausea, retching, and vomiting was significantly higher in the control group (30%) compared to midazolam group (10%). There were no significant hemodynamic changes seen either in midazolam group or placebo. The total mephentermine required to maintain the haemodynamic stability was significantly less in midazolam group (p<0.0001). Conclusions: Subhypnotic doses of midazolam significantly reduced the incidence of nausea and vomiting during caesarian section under spinal anaesthesia, with no significant changes in hemodynamics.
Keywords: Caesarean section, midazolam, nausea, spinal anaesthesia, vomiting
| » CPO-39: Assessment of Adherence to Anti TB Medication for Successful Implementation of Revised National Tuberculosis Programme at a Tertiary Care Hospital, Shimoga- A Crossectional Observational Study | | |
Dharani DR, Shruthi SL, Vedavathi H
Department of Pharmacology, Shimoga Institute of Medical Sciences, Shimoga, Karnataka, India
E-mail: [email protected]
Objectives: This study assessed level of non-adherence to antiTB therapy among patients with pulmonaryTB and compares various factors among adherent and non-adherent TB patients, stressing on reasons for non-adherence at a tertiary care hospital. Methods: This institution based observational and crossectional review was conducted interviewing patients with PulmonaryTB and assesed using Moriskys Medication Adherence Scale-8 (MMAS-8), a pre- tested structured questionnaire based scoring system of patients treated for pulmonaryTB at pulmonary medicine department SIMS, Shimoga. Descriptive statistics were employed. Results: Of total 70 cases interviewed and analysed, 57 were males and 13 females, with mean age group of 41.32±8.63 and mean MMAS score of 2.23±1.87.About 53.33% patients were on continuous phase of treatment.The level of non-adherence were as follows ,High=18%,Medium= 38% and Low= 44% .The most common cause for non-adherence was forgetfulness(66%) reasons being: betterment of symptoms (54%),sickness after taking medication (31%) , distance of travel being far to reach SIMS (15%).Most of the patients were labourers (62%),with low literacy rate and were chronic alcoholics (72%) and smokers (73%).Female patients with moderate literacy level and not addicted to alcohol/smoking showed high adherence compared to males (p<0.05%). Conclusion: As prevalence of non-adherence is high, Especially those Patients who are on continuous phase of TB treatment, there araises immense need for continuous and effective health education to patients' & their family. In addition, patients who are addicted to alcohol & smoking should be targeted with interventions to quit the same,also provide free transport facility to RNTCP/SIMS centres and prompt treatment of adverse effects of drugs, will improve adherence to medication.
Keywords: Adherence, anti-tuberculosis treatment, non-adherence, pulmonary TB
| » CPO-40: A Comparative Study of Effect of Sodium valproate and Flunarizine on Psychomotor Performance in Patients of Common Migraine - A Randomized, Parallel, Open Label, Prospective Observational Study | | |
Bajaj VA1,2, Turankar AV1,2, Thakre M3,2
Departments of 1Pharmacology and 3Psychiatry, Government Medical College, Nagpur, 2Maharashtra University of Health Sciences, Nashik, Maharashtra, India
E-mail: [email protected]
Objectives: To evaluate the effect of valproate & flunarizine on psychomotor performance in patients of migraine with the help of battery of subjective & objective psychomotor tests over a period of 8 weeks. To assess the efficacy of valproate & flunarizine in moderate to severe migraine. To assess the effect of valproate & flunarizine on compliance in patients of migraine Materials and Methods: Patients were allocated to one of the two groups on first day of examination. Baseline psychomotor tests were measured using battery of tests including critical flicker fusion test (CFFT), hand steadiness test(HST), arithmetic abilitty test & reaction time monitoring. At the end of 4 weeks & 8 weeks, again tests using same methods employed previously were performed. Efficacy was calculated by using Migraine dairy template (0, 4, 8 weeks) & CGI Scale (end) & compliance by morisky scale (end). A total of 44 patients were recruited with 22 patients in each arm. Results: On interim analysis, flunarizine (n=8) & valproate(n=7) significantly improved CFFT,HST,AAT,RT scores at the end of 8 weeks compared to baseline & flunarizine significantly reduced frequency (p value =0.0480), duration (p value=0.0195) & efficacy index (p value= 0.0010) when compared with valproate.
| » CPO-41: Assessment of Adherence to Immunosuppressant Therapy in Patients with Psoriasis at a Tertiary Care Hospital: A Cross-sectional Observational Study | | |
Shruthi SL1, Dharani Devangi2, Vedavathi H3, Sriti Hegde4
Department of Pharmacology, Shimoga Institute of Medical Sciences, Shimoga, Karnataka, India
E-mail: [email protected]
Aim: To assess adherence to immunosuppressant therapy in patients with psoriasis and to evaluate factors associated with it. Methodology: The study was conducted in patients > 18 years, of either sex with psoriasis on treatment with immunosuppressant therapy, attending Dermatology OPD at McGann Teaching Hospital, SIMS, Shivamogga for a period of 6 weeks. Drug adherence was assessed using 8- items Morisky Medication Adherence Scale (MMAS- 8). Results were analysed by using appropriate descriptive statistics. Results: Out of 80 psoriasis patients, 47.5 % were males. The mean age was 41.65 + 10.4 years and the mean duration of psoriasis was 20 + 19.03 months. High, medium and low adherence was seen in 10 %, 30 % and 60 % patients respectively. The mean MMAS score was 5.31 + 1.76. The most common cause of non-adherence was inconvenience in taking medicine daily (47.5 %), followed by improvement in symptoms (45 %) and forgetfulness (37.5 %). High literacy level and non-consumption of alcohol were significantly associated with high adherence (p<0.05) whereas gender, age, marital status, smoking and presence of comorbid conditions had no impact on it (p>0.05). The most common immunosuppressant used was a topical steroid clobetasol. Conclusion: Adherence to treatment by patients can be optimized by ensuring an effective doctor–patient relationship; optimism with the treatment prescribed; limiting treatment induced side-effects and hassles of use and by involving patients' care givers.
Keywords: 8- items morisky medication adherence scale, adherence, immunosuppressant, psoriasi
| » CPO-42: Efficacy of Supplimentation of Probiotics Along with Antimicrobial Agents in Vulvovaginal Infections in a Tertiary Care Hospital | | |
Deepa P, Umakanth NP, Prema P, Raghuprasada MS
Departments of Pharmacology and OBG, SS Institute of Medical Sciences and Research Center, Davangere, Karnataka, India
E-mail: [email protected]
Objectives: To ascertain the efficacy of probiotics along with antimicrobials in the treatment of vulvovaginitis. To evaluate the rate of recurrence. Methodology: The study included 60 patients, divided into two groups of 30 each. After obtaining ethical committee clearance one group received standard treatment including antibacterial, antifungal as per the gynecologist discretion and in other group along with standard treatment, probiotic capsules containing combination of Saccharomyces. Boulardii, Lactobacillus. Sporogenes (50millions), Streptococcus. Faecalis (30million), Clostridum. Butyricum (2million), Bacillus. Mesentricus (1million) given orally twice daily and follow up is done for a period of 3 months. The drugs were started on 5th day after menstruation taking starting of the bleeding as day 1. Informed consent was taken from all patients. Results: The parameters compared were, Symptoms and signs (significant p value), Clue cells (significantly reduced in number), Recurrence rates (significantly reduced), in 80% of patients smears were not consistent with BV. Maximum number of patients showed negative KOH mount (71.5%), Saline wet mount was negative in 80% of patients in antimicrobial agents + probiotics group. Conclusion: From the present observational study, probiotics along with antimicrobial agents showed better improvement than antimicrobial agents alone. Hence supplementation of probiotics along with antimicrobial agents provide better efficacy than antimicrobial agents alone in treating vulvovaginal infections.
| » CPO-43: A Study on Prescribing Pattern of Antihypertensive Drugs in Diabetic Patients at a Tertiary Care Teaching Hospital | | |
Bhowmik Smita
Department of Pharmacology, Gauhati Medical College and Hospital, Guwahati, Assam, India
E-mail: [email protected]
Objective: To evaluate the utilization and effects of antihypertensive drugs as well as to compare the effectiveness of different types of antihypertensive drugs in treating diabetic subjects with hypertension. Methods: This study is a prescription-based, observational, prospective study conducted since June 2017 in the Department of Endocrinology, GMCH after getting approval from Institutional Human Ethics Committee and included both indoor and outdoor patients of age above 18 years. Patients with malignant hypertension, advanced renal failure and pregnant woman were excluded. Results: In our study, a total of 236 diabetic patients receiving antihypertensive drugs were included. Among these, 131 were male and 105 were female. Diabetic patients receiving monotherapy of antihypertensive drugs were 64.83%, dual drug therapy were 25.85%, triple drug therapy were 8.4% and quadruple drug therapy were 0.84%. Amongst monotherapy, ARB was most prescribed drug (58.47%), followed by CCB (39.83%), Diuretics (28.81%), ACE inhibitor (12.71%),Beta-blocker (4.67%) and others (0.84%). Associated co-morbidities were COPD (30.93%), IHD (11.01%), CKD (9.74%), Hypothyroidism (6.78%) and CVA (2.96%). Diabetic patients with systolic BP in controlled stage were 19.07%, Stage-I were 47.03%, Stage-II were 33.9% and diastolic BP in controlled stage were 50.89%, Stage-I were 36.86%, Stage-II were 12.29%. Mean blood glucose level was 310+/-20 in male and 280+/-20 in female. After treating these diabetic patients with antihypertensive drugs without altering their hypoglycaemic medications, the mean blood glucose level for male was 220+/-20 and female was 190+/-20.The most common age group involved in our study was 61-80 years (44.06%). Conclusion: In diabetic patients with hypertension, it seems important to achieve blood pressure goals than glycemic goals to avoid serious complications of hyperglycaemia and for better glycemic control.
| » CPO-44: Adverse Drug Reaction Monitoring and Experiences from a Teaching Tertiary Care Centre and Hospital of Southern India | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To monitor and assess the causality of adverse drug reactions reported from a teaching tertiary care centre and hospital of southern India. Methods: This study was conducted in a teaching tertiary care centre and hospital located in a Southern part of India, over a period of two months. It was a prospective observational based study during the months of January and February 2015. The study proposal was approved by the Institutional Human Ethics Committee [IHEC]. The collected ADRs from tertiary care centre and hospital were analysed using various ADR causality assessment scales [WHO, Naranjo Algorithm, Schumock & Thornton and Modified Hartwig and Siegel scales]. Results: A total of one hundred and ninety four ADRs were reported during the months of January and February 2015. It was found that drugs related to the autocoid system [22.68%] were responsible for maximum causation of ADRs, followed by drugs related to the antimicrobial classes [22.16%], GIT system [11.86%], endocrinal system [9.28%], CVS [5.67%], CNS [4.12%], respiratory system [2.58%], Blood [0.52%], autonomic nervous system [0.52%] and drugs acting on other/multiple systems [20.62%]. ADR causality assessment by WHO scale revealed, maximum number of ADRs were possible [50.52%] followed by probable/likely [20.10%], unlikely [14.43%], conditional/unclassified [9.79%] and unclassifiable as [5.15%]. It was seen in Naranjo algorithm scale that ADRs were possible in 75.77%, probable in 18.56% and definite in 5.67% of cases. Modified Hartwig and Siegel scale found 71.65% of ADRs were mild in nature followed by 23.71% as moderate and 4.64% as mild in nature. The Schumock & Thornton preventability scale identified 42.78% of all ADRs were definitely preventable, 30.41% as probably preventable and rest as not preventable. Conclusion: This study showed that autocoid related drugs were responsible for maximum number of ADRs and drugs related to blood and autonomic nervous system contributed for least number of ADRs. Causality assessment of ADRs revealed that, maximum number of the ADRs were possible in both the WHO and Naranjo scales. It was also seen that, maximum number of ADRs were mild in nature on Modified Hartwig and Siegel scale; and definitely preventable on Schumock & Thornton ADR preventability assessment scale.
| » CPO-45: A Study of Knowledge, Attitude and Practices towards Clinical Principles of Pharmacovigilance among Postgraduates of Nursing College | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the knowledge, attitude and practices towards the clinical principles of Pharmacovigilance among postgraduates of nursing college. Methods: This study was a cross-sectional questionnaire based snapshot about the knowledge, attitude and practices towards the clinical principles of Pharmacovigilance among postgraduates of nursing college. The study research proposal was cleared by the Institutional Human Ethics Committee [IHEC] and prior written informed consent was obtained from all the study participants. Questions on Pharmacovigilance were prevalidated and were distributed among nursing postgraduates and were asked to return the same after its complete filling. The data from the complete forms were recorded in the Microsoft office 2007 excel sheet and were subjected for descriptive statistics. Results: A total of [n=30] study participants were taken for final data analysis. The study confirmed that, most of the study participants were answered the correct responses to the questions related to the knowledge domain of clinical principles of Pharmacovigilance and the correct response rate was more than 52%. It was also observed that most of the study participants had positive attitude towards the Pharmacovigilance with opinion of making mandatory reporting of ADRs [>71%] and more than 92% were willing to undergo training in this area for inculcating the good Pharmacovigilance practices in their profession. However, this study revealed that, only less than one fourth of study participants were reported ADRs to the ADR monitoring centre in their institution. Conclusion: This study showed that, there was a fair knowledge with poor practices towards the clinical principles of Pharmacovigilance among postgraduates of nursing college, based in Southern India. Interestingly study also showed that, there was a positive attitude towards the Pharmacovigilance clinical principles and the poor practices towards the Pharmacovigilance among nursing postgraduate students can be improved by encouraging through various educational CME/symposia programmes with better institutionalized policies.
| » CPO-46: A Snapshot of Cognizance of Medical Research Principles among Undergraduate Trainees of Southern Nursing Tertiary Care Centre and Hospital | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected].
Objectives: To study the cognizance of medical research principles among undergraduate trainees of southern nursing tertiary care centre and hospital. Methods: The study proposal was approval by the Institutional Research Committee [IRC] and Institutional Human Ethics Committee [IHEC]. The study participants were informed about the study in detail and written consent was obtained from the participants before enrolling them into the study. This study was a cross-sectional questionnaire based survey conducted on undergraduate trainees of southern nursing tertiary care centre and hospital over a period of one year. The obtained data was entered into the MS office excel sheet and the confidentiality of the study participants was maintained throughout the study period. Results: The study participants had good knowledge on medical research with correct response rate of more than 59% to the questions comprising on various sections of the biomedical research principles. It was also seen that, more than 82% of study participants willing to undergo training in the biomedical research to update their knowledge periodically. The practices towards the research was also found to be satisfactory among undergraduate trainees of southern nursing tertiary care centre and hospital with more than half of the study participants were involved in some kind of basic research with presentation of research work in various conferences either in the form of poster or oral. Conclusion: This study revealed, there was a fair knowledge, positive attitude with satisfactory practices towards the medical research principles among undergraduate trainees of southern nursing tertiary care centre and hospital.
| » CPO-47: Second Year Dental Students and Their Perception towards the Pharmacovigilance Programme of India (PvPI): A Descriptive Analysis | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Science, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the perceptions about Pharmacovigilance Programme of India [PvPI] among second year dental students in a teaching institution from Southern part of India. Methods: A study was done in a teaching tertiary care centre involving second year dental students. The study approval was obtained from ethics committee and a prior consent was obtained from all the study participants. It was a cross-sectional in design and prevalidated questionnaire was provided to study participants and were assessed their perceptions towards the Pharmacovigilance Programme of India [PvPI]. Results: Total [n=62] second year dental students were enrolled into the study for descriptive statistical analysis. Regarding the questions based on knowledge domain of PvPI, almost more than 55% study participants had lack of knowledge in this field. Most of the participants had good opinion [more than 80%] regarding establishment of ADR monitoring centre at every hospital and more than 92% were of optimistic and willing to be trained in this area. However again it had been noticed that, the practices regarding the PvPI were very poor with only less than 12% had experience in reporting the ADRs to the monitoring centers. Conclusion: There was a lack of knowledge but positive attitude towards the Pharmacovigilance Programme of India [PvPI] among second year dental students in a teaching institution from Southern part of India. This study also revealed, the poor practices towards the PvPI among second year dental students, can be enhanced by incorporating better policies at institutional level.
| » CPO-48: Study of Impact of Antidepressant Drugs on Quality of Life in Patients of Major Depressive Disorder | | |
Bhagyashree Mohod, Renuka L Kadam, Smita Sontakke, VM Motghare, Prashant Tipale1
Departments of Pharmacology and 1Psychiatry, GMCH, Nagpur, Maharashtra, India
E-mail: [email protected]
Objective: To assess the effect of Amitriptyline, Escitalopram and Vilazodone on QOL in patients of major depressive disorder. Methodology: This open-label, comparative, cross-sectional, observational study. Patients of MDD are being enrolled and assigned to one of the following groups. Group 1: newly diagnosed patients. This is further divided into sub-groups based on the treatment received 1a) Tab.Amitriptyline, 1b) Tab. Escitalopram, 1c) Tab.Vilazodone. Group 2: patients who have completed 12 weeks of treatment on any one of the above mentioned antidepressants and will be further divided into subgroups 2a) Tab. Amitriptyline, 2b) Tab. Escitalopram, 2c) Tab.Vilazodone. Patients were subjected to Hamilton Depression Rating Scale-17 items (to assess severity of depression) and Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (QLEQSF) and 36 item Short Form Health Survey (SF36) to assess effect of drugs on QOL. Results: In the present study it was found that there is statistically significant improvement in Amitriptyline (P < 0.003), Escitalopram (P < 0.001) and Vilazodone (P < 0.03) group in QLEQSF score from baseline after 12 weeks of treatment. Also shows statistically significant improvement in mental component summary and physical component summary of SF-36 score after 12 weeks of treatment. Vilazodone and escitalopram shows statistically significant results than amitriptyline (P < 0.05) in HAMD 17 score. Ecsitalopram produced significantly better results compared with amitriptyline in QLEQSF score (P <0.05). Also Vilazodone produced significantly better results compared with amitriptyline (P < 0.001) and escitalopram (P <0.05) in QLEQSF score. Vilazodone produced significantly better results compared with amitriptyline in the SF-36 mental component (P <0.001) and in 2 domain scores vitality/energy (P< 0.005) and social functioning (P <0.05). Conclusion: The study is ongoing and will be completed in January ending. This is a result of interim analysis. Till now study concludes that all the comparator arms (Vilazodone, Escilalopram and Amitriptyline) improves Quality of life after 12 weeks of treatment in patients of major depressive disorder.
Keywords: Amitriptyline, escitalopram, MDD, QOL, vilazodone
| » CPO-49: Evaluation of Drug Awareness in CKD Patients and their Caregivers | | |
Patil ML, Tripathi RK1, Jamale TE, Pilliwar CP1, Gajbhiye SV1
Departments of Pharmacology and Therapeutics and 1Nephrology, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: 1. To study drug awareness and evaluate self-medication in CKD patients. 2. To assess drug awareness in CKD patient's caregiver. Methods: Single centre, cross-sectional study was conducted in nephrology OPD in the year 2017 after getting IEC approval. Two separate questionnaires on drug awareness and self-medication were designed and validated. The questionnaires had 8 items each for drug awareness and self-medication. Responses for questions were recorded on a 4-point scale. Results: Out of 110 patients approached 90 patients consented to participate in the study. 81% (n=73) were familiar with medications given in their prescription. 1.36% (n=1) could tell the complete treatment information. 40% (n=36) patients knew the indication of medication. More than 90% were taking medications on regular basis. Only 1.11% (n=1) had information about side effect profile of treatment. 8.62% (n=5) had information about precaution to be taken on single missed dose. 50% (n=19) patients self-medicated paracetamol. 10% (n=9) patients were taking herbal medicines without doctor's consultation.We administered questionnaire to 27 caregivers. 62.96% (n=17) caregivers could identify the prescribed medication. 29.41% (n=5) caregiver had complete information of treatment. 44.44% (n=12) caregiver had information about medication. None of the caregivers had any idea about side effect profile of therapy. Conclusion: There is lack of patient awareness towards the CKD therapy. The tendency of self-medication among CKD patients is high. There is scarcity of knowledge in caregivers regarding therapy.
| » CPO-50: A Study of Relation between Polypharmacy and Under-prescribing in the Elderly | | |
Naik MN, Nerurkar RP
Department of Pharmacology, Topiwala National Medical College, BYL Nair Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: Inappropriate prescribing which includes both under and over prescribing; is a common medication error and has been linked to a higher incidence of adverse effects in the elderly.The present study aimed at identifying the relation between number of medications (polypharmacy ) and PPOs (under prescribing) in elderly hospitalized population. Methods: A retrospective analysis of inpatient hospital records of 250 elderly patients admitted to the institution was carried out. The number of drugs in each prescription was studied to identify the incidence of polypharmacy. In addition, each prescription was assessed in accordance with the START tool for detection of inappropriate prescribing to identify the potential prescription omissions (PPO). The association between number of medications (polypharmacy) and presence of PPO was studied using Chi-square test of statistical analysis. Results: An incidence of PPOs of 9.4% (23 instances out of 250 prescriptions) was detected in the study according to the START tool of analysis. The study was able to detect a significant association between number of medications and prescription omissions. (p value -0.0017). Conclusion: This study is one of the fir st studies to detect an association between polypharmacy and under-prescribing in elderly population. This brings to the forefront an important factor contributing to prescription omission related errors in geriatric population which is polypharmacy. It is evident that an increase in the number of drugs prescribed may lead to potential omissions of important medications in the elderly. Awareness of this problem and education of healthcare practitioners in geriatric pharmacology may be an effective measure against this problem.
| » CPO-51: Effectiveness of Intravenous Magnesium Sulphate in the Treatment of Acute Organophosphorus Poisoning | | |
Ghimire R, Bajaracharya SR, Prasad PN1, Lamichhane S
Departments of Clinical Pharmacology and 1Maharajgunj Medical Campus, Institute of Medicine, Kathmandu, Nepal
E-mail: [email protected]
Objectives: This study is carried out to find out the effectiveness of intravenous MgSO4 in the treatment of acute OP poisoning. Materials and Methods: Patients with moderate to severe OP poisoning and fulfilling the inclusion criteria were included in the study. Out of 45 patients, only 30 patients met the inclusion criteria and were randomly allocated to the two arms of the study by simple lottery system. Half of the patients received only the standard treatment and were considered as the control whereas the other half who received MgSO4 in addition to the standard treatment were kept in the intervention group. Single dose of 4g MgSO4 (20%) was given to the treatment group. The comparisons between two groups were done in terms of mortality and duration of hospital stay. Results: Chlorpyrifos was the most common compound ingested. Mean duration of hospital stay in cases and controls were 6.33 and 6.73 days respectively and the difference was not statistically significant. There was no mortality in case and control group. Conclusions: MgSO4 has no advantage in reducing duration of hospital stay and mortality in OP poisoning patients.
Keywords: Magnesium sulphate, management, organophosphorus, poisoning
| » CPO-52: Study of Awareness of Diabetes Mellitus among Diabetics and Non-diabetics and Drug Utilization Pattern in Diabetics Attending Tertiary Care General Hospital in India | | |
Krishnakanth K, Kumar P
Department of Pharmacology, NRI Medical College and Hospital, Guntur, Andhra Pradesh, India
E-mail: [email protected]
Background: Diabetes Mellitus (DM) is one of the most challenging public health problems. It is important to know about the awareness level of a disease condition in diabetic and non diabetic population, which plays a vital role in future development, early detection and prevention of disease. Methodology: 200 subjects were interviewed and their details were noted in a case record form. The questionnaire contained a series of questions related to demographic characteristics and awareness of DM including general knowledge, risk factors and complications. Results: Among 200 patients, 150 subjects were diabetic and 50 were non-diabetic. 60 (40%), 14 (28%) of diabetics and non- diabetics were in between the age of 41 – 50 years. 101 (67.3%) were males, 49 (32.6%) were females. 45 (44.5%) diabetic and 20 (40.81%) non-diabetic males know the risk factors for diabetes mellitus and 35 (34.6%), 21 (42.8%) were aware of symptoms, 09 (8.9%), 03 (6.1%) had awareness on complications of diabetes. 21 (20.7%), 06 (12.2%) doesn't know about the Risk factors. Conclusion: The present study conclude the current situation of knowledge and awareness of diabetes mellitus and also emphasizes the need for improvement in knowledge and awareness on diabetes mellitus among the diabetic as well as non-diabetic subjects in order to achieve prevention and better control of diabetes risk factors, complications and its management.
Keywords: Attitude, diabetes mellitus, diabetics, knowledge, non diabetics
| » CPO-53: Causality, Severity and Preventability Assessment of Adverse Drug Reaction in a Tertiary Care Hospital in India | | |
Tondare SB, Belhekar MN, Pandit PR, Bhave KA, Patel TC, Kokne ML
HBT Medical College and Dr. R. N. Cooper Muncipal General Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Adverse drug reactions (ADRs) are the major public health problem and are considered to be a leading cause of morbidity and mortality. The aim of this study was to evaluate incidence and pattern of ADRs, Causality, Severity and Preventability of ADRs. Methods: Data was collected and analysed with the information such as patient demographic details, drug history, associated co-morbid conditions prospectively. WHO scale was used for assessing Causality, Modified Hartwig scale was used for assessing Severity and Modified Schumock and Thorntons Scale were used for assessing Preventability of ADRs. Analysis was done in percentages and proportions. Results: Total 154 ADRs were reported during a period of 12 months (Aug 2016- July 2017). Male predominance (52.8%) with 75.3% patients falling in 19-60 years, 21.4% in pediatric and 0.3% geriatric age group. The most common ADR was skin reactions (43.5%) and the most common causative drug class for the same was found to Antimicrobials class (46.7%) followed by analgesic/anti-inflammatory/antipyretic (15.6%). Causality assessment scale indicated 68.8 % ADRs as possible and 24 % ADRs were probable. Severity assessment revealed that 45.5 % was mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 15.6% of the cases were probably preventable. Conclusions: Most of the ADRs in the present study were of possible category with mild to moderate severity and non preventable. Antimicrobial drug class being the most common offending class. Strategies targeting these drug classes may reduce the number of ADRs and possibly the associated costs.
| » CPO-54: The Correlation of Amyloid Peptides with FDG PET Scan in Diagnosis of Alzheimer's disease | | |
Soni H, Medhi B, Modi M, Goyal MK, Mohanty M, Ashok Kumar, S. Phulan, Vishny VY
Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
E-mail: [email protected]
Background: In Alzheimer's disease (AD) pathology starts with formation of small, soluble oligomers of Aβ1-42 which on accumulation forms neuronal plaques which lead to the neuronal death. The present study we have used plasma level of Aβ1–40 and Aβ1–42 amyloid peptides in diagnosis of AD. Materials and Methods: We screened 152 patients with memory complained in outpatient department of neurology, between 2014 to 2015 and enrolled 47 old aged (>50yrs) demented patients who fulfilled the diagnostic criteria for dementia, AD and Mild Cognitive Impairment (MCI) with adequate vision and hearing. Aβ1–40 and Aβ1–42 plasma level were estimated by ELISA kit. We had also done FDG PET Scan of 17 AD, 12 MCI patients and correlate plasma amyloid peptide with PET Scan. Results: Aβ1-42 level was significantly high in AD patients as compared to controls. We found significant correlation with the FDG PET Scan and the ratio of plasma amyloid peptides Aβ1–40 and Aβ1–42 in the right and left parietal association area, right and left temporal association, right and left frontal association, right and left posterior cingulate and global average. Conclusion: According to present study results it can be concluded that high plasma concentration of Aβ1-42 amyloid peptide by ELISA method can be used as an additional diagnostic biomarker in the Alzheimer disease. As ELISA method is simple, easy to perform, cost effective and less time consuming and the negative test result can exclude the dementia patients from the diagnosis of Alzheimer disease.
| » CPO-55: Comparative Evaluation of Effects of Aripiprazole and Olanzapine using Ketamine Induced Rat Model of Schizophrenia on Heart Rate Variability: An Emerging Parameter of Cardiovascular Complications | | |
Bhargava V, Acharya CR
Department of pharmacology, Government Medical College, Veer Narmad South Gujarat University, Surat, Gujarat, India
E-mail: [email protected]
Objectives: As compared to general population, schizophrenic patients have higher cardiovascular morbidity and mortality, which may be due to cardiac autonomic dysfunction.Presently, there is paucity of data regarding cardiovascular safety of atypical antipsychotics.We aimed to test if olanzapine & aripiprazole affect cardiac autonomic function. Materials and Methods: In this study, total 36 male albino rats weighing 150-250 grams were divided into 6 groups equally. Group I was given distilled water for 28 days. Ketamine was given intraperitoneally for 7 days in remaining 5 groups. Then, olanzapine at low dose and high dose was given by intraperitoneal injection in group III, IV while aripiprazole was given orally at low dose and high dose in group V & VI respectively for next 21 days. 24 hours after the last administered dose, a computer-assisted, 5-min measurement of resting Heart Rate Variability (HRV) was done to evaluate functional aspects of autonomic nervous system activity. Results: There was no deviation found in all the time domain as well as frequency domain parameters of HRV in all the six groups i.e. distilled water treated group, ketamine treated group, low and high doses of olanzapine and aripiprazole treated group respectively. Conclusion: This data suggests that the sympathetic & parasympathetic modulation of HRV remains unchanged even during olanzapine and aripiprazole treatment. Both olanzapine and aripiprazole can be considered as safer drugs to be used as antipsychotics without causing cardiovascular complications in terms of alteration in HRV.
Keywords: Aripiprazole, heart rate variability, olanzapine
| » CPO-56: Patterns of Drug Use and Factors Affecting Non-adherence to Medications in Adult Patients with Systemic Lupus Erythematosus: A Prospective, Observational, Hospital Based Study | | |
Toms T, Anuradha S, Shobha V1
Department of Pharmacology, St John's Medical College, RGUHS, 1Department of Immunology and Rheumatology, St John's Medical College Hospital, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: Among SLE patients attending a tertiary care centre; to evaluate patterns of drug use, assess rate and predictors of medication non-adherence over 6 months. Methods: We conducted a prospective observational study in a tertiary care hospital over 6 months. We measured medication non-adherence using patient recall method for the previous month. Less than 80% of medication taken on an average per month were considered non-adherent. Demographic, clinical and medication details were summarised using descriptive statistics and analysed using inferential statistics. Multivariate logistic regression was used to determine the predictors of non-adherence. Results: We recruited 95 patients and 85(92.6%) were females. Patient's mean age was 33.7(±10.9) years, 58.9% were from rural domicile. Mean duration of illness was 5.8 (±4.4) years and 68.4% had at least one comorbid condition. Most commonly prescribed drug was hydroxychloroquine 88.4%, followed by prednisolone 85.3%. At baseline 31 of 95(32.6%) and at 6 months 22 of 86(25.9%) participants were non-adherent to medications. At baseline (OR, 6.72; 95% C.I, 2.07, 21.79; p=0.002) and at 6 months (OR, 4.82; 95% C.I, 1.36, 17.0; p=0.015) irregular follow up was a significant predictor of non-adherence. Dose of prednisolone was a significant predictor of non-adherence (OR, 1.17; 95% C.I, 1.01, 1.37; p=0.043) at 6 months. Conclusion: In our study HCQ was most commonly prescribed drug. About a quarter of patients were non-adherent and irregular follow up was the consistent predictor. Strategies to regularise the follow up rates might improve the medication adherence in SLE patients.
| » CPO-57: Dihydroquercetin (DHQ) Acts on LXR/Maf-1 Pathway for its Anticancer Effects on DMBA-induced Breast Cancer | | |
Shakti P Pattanayak, Wasimul Haque, Pritha Bose, Usman Mohd Siddique1, Abhishek Kumar, Priyashree Sunita2
Department of Pharm. Sciences and Technology, Division of Advanced Pharmacology, Birla Institute of Technology, 1Department of Pharm. Sciences and Technology, Division of Pharmaceutical Chemistry, Birla Institute of Technology, 2Department of Health, Education and Family Welfare, Government Pharmacy Institute, Government of Jharkhand, Ranchi, Jharkhand, India
E-mail: [email protected]
Aim: 7, 12-dimethylbenz (a)anthracene (DMBA) is involved in initializing cascades of signaling events causing alteration of different enzymes responsible for lipid and glucose homeostasis increasing availability and consumption of energy producing molecules for the cancer development. 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoAR) is a key enzyme modulating cholesterol synthesis pathway whereas liver-X-receptor (LXR) regulates lipid, carbohydrate metabolism in various malignancies including mammary cancer. In this study, Dihydroquercetin (DHQ), a potential flavanoid has been evaluated for its anti-cancer potential on Mammary-carcinogenesis (MC). Methods: We performed molecular docking analysis of DHQ on LXRα, LXRβ, HMG-CoAR, mTOR and PTEN using MAESTRO tool comparing with their reference ligands followed by administration of DHQ at different doses (10, 20 and 40mg/kg b.wt./day) for determining its chemotherapeutic potential in DMBA induced MC. mRNA and protein estimations were done using RT-qPCR and western blot respectively. Results: The docking analysis demonstrated DHQ to interact significantly with LXR (α & β), HMG-CoAR, mTOR and PTEN. which was validated with the enzyme inhibition assay using HMG-CoAR (EC 1.1.1.34). DHQ inhibited HMG-CoAR activity with an IC50 value of 97.54±2.5nM. DHQ significantly restored the cancer-induced variations in body-weight, tumor growth and lipid, lipoproteins, Lipid Metabolizing Enzymes, glycolytic enzymes thereby modulating energy regulation in DMBA-induced MC. DHQ also interacted with LXRs, HMG-CoAR and metabolic enzymes, thus successfully restoring the altered metabolism responsible for accelerating the uncontrolled proliferation of cell in MC. Moreover, DHQ also changed the mRNA and protein expressions of HMG-CoAR, LXR (α, β), Maf 1, PTEN, PI3K, Akt, mTOR, FASN and ACC1 dose dependently.
| » CPO-58: Assessment of Awareness of Knowledge, Approach and Practices of Nursing Students on Witnessing and Recording of Adverse Drug Reactions in a Tertiary Care Teaching Hospital | | |
Raghuprasada MS1, Deepa Patil2, Geetha S3, Umakant N Patil4
Department of Pharmacology, SS Institute of Medical Sciences and Research Centre, Davangere, Department of Pharmacology, East point college of Medical Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: To assess the knowledge, approach and practices of nursing students on witnessing and recording of adverse drug reactions in a tertiary care hospital, Methodology: This feedback form based study was conducted in a tertiary care hospital on 85 Pre final and final year nursing students. The study mechanism was a pre designed questionnaire which included the Knowledge of ADRs reporting, the approaches towards reporting, and the factors which could hinder the reportage. The students were given an educative and communicating session for clearance of their understanding about Pharmacovigilance. The post-session feedback form was also completed to assess their understanding. Results: A total of 85 students participated. The median awareness, attitude scores before the intervention were 42.5%, 46.6% respectively. After the intermediation the scores increased significantly to 89.4%, 98.8% respectively. Conclusion: The interaction with students was effective in improving the student's awareness, attitude towards ADRs & Pharmacovigilance. Further such studies will help in intended reporting of adverse drug reactions which can augment the of Pharmacovigilance program in India.
| » CPO-59: Comparison of Antihyperglcemic Activity of Teneligliptin (20mg/d) with Sitagliptin (100mg/d) as an Add-on to Metformin in Patients of Type 2 Diabetes Mellitus (T2DM) - An Observational Study | | |
Rane PS, Dange SV, Shidore PP
Department of Pharmacology, Dr. DY Patil Medical College, Pune, Maharashtra, India
E-mail: [email protected]
Background: Teneligliptin is a new DPP-4 inhibitor, available in India.It has been widely prescribed in type 2 diabetes mellitus (T2DM) due to its low cost. However,there are few studies comparing it with other DPP-4 inhibitors. Objective: To compare the efficacy of teneligliptin with sitagliptin in patients of T2DM. Methods: Patients of T2DM,attending the OPD of Dhanashree Hospital,New Sangavi;during the period of January 2017 to August 2017 were scrutinized.Those uncontrolled on metformin monotherapy(1g/d) were selected and were administered either sitagliptin(100 mg/d) or teneligliptin(20mg/d) in addition to metformin.Base-line clinical features (age,sex,body-weight,BP,pulse rate etc.)and laboratory parameters (Hemogram,BSL-F & PP,GHb,SALT,serum creatinine etc.)were recorded initially and at the end of three months.Side effects were assessed with the help of a questionnaire.The data obtained were analyzed by Student´s “t” test.P< 0.05 was considered as statistically significant. Results: Thirty five patients were treated with sitagliptin,while 32 received teneligliptin.After 12 weeks of therapy, it was observed that FBSL(S:158.4 vs.135.1;T:156.2 vs.135.6 mg/dl), PPBSL (S:241.1 vs.192.9 ;T:238.4 vs.195.3 mg/dl) and HbA1c (S:7.54 vs.6.64 %;T:7.52 vs.6.92 %)were significantly reduced in both the groups as compared to base-line values.Both drugs were well tolerated.There was no significant difference in the glycemic parameters between the two groups at the end of the study. Conclusions: Teneligliptin significantly improved glycemic control in patients with T2DM when prescribed as an add-on to metformin. It was equally effective as compared to sitagliptin.As teneligliptin is less costly than other gliptins,it may be considered as a good cost-effective option as an add-on to metformin in patients of T2DM.
Keywords: Metformin, sitagliptin, T2DM, teneligliptin
| » CPO-60: A Cross-sectional Study on the Prescribing Pattern of Antimicrobial Agents among Medicine Inpatients of a Tertiary Care Teaching Hospital | | |
Kakkar S, Jain M
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India
E-mail: [email protected]
Objectives: Antimicrobial agents are the mainstay of treatment in modern medicine. In view of emerging threat of Antimicrobial Resistance (AMR), there was a requirement felt to identify determinants & patterns of antimicrobial prescribing. The prescribing pattern of antimicrobial agents among the medicine inpatients of SMS Medical College & Hospital, Jaipur was studied. The objectives were to evaluate, monitor and suggest modifications in prescribing practices to make medical care rational. Methods: This was a Cross-Sectional Study which was done for a period of one year from July 2016- June 2017. The rationality of antimicrobial drug use was evaluated by analyzing the prescriptions. Results: A total of 400 patients were included in the study. Percentage of hospitalizations with one or more antimicrobials prescribed was 48.75%. The average number of antimicrobials prescribed during hospitalization was 1.67. Percentage of antimicrobials prescribed consistent with the Essential Medicines List was 89.73%. The most commonly prescribed antibacterial group in medicine in patients was Beta Lactams at 57.29%, followed by Oxazolidinones and Tetracyclines that accounted for 12.85% and 11.11% respectively. Conclusion: AMR is closely linked to inappropriate antimicrobial use. This study suggests that certain interventions are required to minimize toxicity and lessen the chances of emergence of resistance. It is proposed that there should be continuous education on rational use of drugs among health care professionals.
| » CPO-61: Hyperbilirubinemia during Atazanavir Treatment in HIV/AIDS Patients Taking Second Line ART Drugs | | |
Desai S, Harinika G
Department of Pharmacology, Gulbarga Institute of Medical Sciences, Gulbarga, Karnataka, India
E-mail: [email protected]
Objective: To estimate the incidence of atazanavir associated hyperbilirubinemia in HIV patients receiving second line antiretroviral regimen (Tenofovir + Lamivudine + Ritonavir boosted Atazanavir) advocated by National AIDS Control Organisation (NACO) by measuring serum bilirubin levels. Methods: The study was done in 100 HIV-infected patients attending ART Plus centre at a tertiary care centre receiving atazanavir regimen for a period of 12months. The bilirubin levels in blood were estimated by MALOY & EVELYN METHOD. the analysed data was expressed in percentages [n (%)]. 't' test and Chi square test were applied. P value < 0.05 was considered significant (0.01). Results: Out of 100 patients, 71 were males and 24 were females. It was found that 52.6% (n=50) of HIV patients who were on atazanavir regimen showed hyperbilirubinemia. Hyperbilirubinemia was more in the age group of 36-45 years accounting for 48.0% (n=24). Incidence of hyperbilirubinemia was measured and graded. Grade I hyperbilirubinemia was 26%, grade II was 24%, grade III was 48% & grade IV 2%. 55.0% (n=22) of males and 20.0% (n=10) of females had grade III hyperbilirubinemia. The Study data suggested that atazanavir-associated hyperbilirubinemia is common and self-limiting. Conclusion: It was observed that most of the HIV/AIDS patients receiving atazanavir containing ART regimens developed hyperbilirubinemia, so these patients should be regularly monitored for atazanavir induced hyperbilirubinemia.
Keywords: Acquired immunodeficiency syndrome, atazanavir, HIV, hyperbilirubinemia, NACO
| » CPO-62: Obstacles in Rational use of the Fixed Drug Combinations | | |
Ravi Naik Nunavath, G Arunjyothi, T Chakra Dhār, Resu NehaReddy, Sothuku Shasikanth, Hajra Irsad
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E-mail: [email protected]
Introduction: Fixed drug combinations improve the patient compliance, decreases pill burden and decreases the cost of the drug, but at the same time it is associated with the irrational use. One of the most common obstacle is difficult to find out the causative drug causing the adverse effect in FDC's. Objective: To analyse the obstacles in rational use of FDC's. Methods: It is observational study, case reports has been collected from a tertiary care centre. Results: 6 cases of HIV who developed skin rashes after one week of initiation of TLE (Efavirenz lamivudine , tenofovir ) regimen and 6 Cases of Tuberculosis who developed hepatitis after initiation of FDCs (isoniazid, rifampicin, pyrazinamide) regimen has taken both the regimens are approved by local drug regulatory authority (DCGI),since in TLE regimen all the drugs can cause the rashes and in Tuberculosis all the 3 drugs in FDC can cause the hepatitis so it would be difficult to identify the causative drug which is causing the adverse effect .To address the adverse effect all the drugs in regimen should be stopped but the drugs causing these adverse effect can be one or more which can be known by rechallenge of the drug, It can be possible only in Tuberculosis but not in HIV since it can cause more sever adverse effects. Conclusion: To avoid such obstacles it can be suggested to prescribe the individual drugs one after other in conditions where these adverse effects are common and in a condition where it will not affect the outcome of the underlying disease.
| » CPO-63: Unclear Aspects of Ayurvedic Medicines Imperilling One's Natural Life | | |
Resu Neha Reddy, Gaddameedhi Arun Jyothi, T Chakradhar, Sothuku Shashikanth, RaviNaik Nunavath, Orooj Fathima,
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E-mail: [email protected]
Introduction: Ayurveda is an ancient healing system emanated to ameliorate illness by using natural ingredients like herbs to cure diseases. Though there is growing interest in using ayurvedic medicine as a safer option, it is thwarted because its effectiveness and safety are not backed with evidence and clinical data. Objective: To understand the importance of clinical trials in ayurvedic medicine. Methods: A prospective observational study conducted at tertiary care centre, where 4 cases were reported with skin rashes (out of which 2 cases reported to have Steven Johnson syndrome), after an exposure to an unknown ayurvedic medications. The symptoms were relieved within 10 days after the ayurvedic medications were discontinued. Results: It was observed that there was a positive correlation between causative agent and adverse drug reactions, as there is improvement in the symptoms after de-challenge (after expunging the ayurvedic medication). On history, it was observed that the medications were given by local quack or uncertified ayurvedic physician. The medications are unauthorised as there was no prescription for the given indication and the medications were devoid of authentic data about the safety and efficacy from local regulatory authorities. Under-reporting is the most common drawback in adverse drug reactions by unprincipled use of ayurvedic medications. Conclusion: Establishing stringent and uncompromising regulatory guidelines by Drug Control General of India (DCGI) to monitor adverse drug reactions, to create awareness among patients and health professionals, to monitor risk-benefit profile, to generate evidence-based recommendations on the safety of medicines, to terminate fraudulent practitioners, to conduct clinical studies prior prescribing the ayurvedic medications by the professional doctors to the patients can be endorsed.
| » CPO-64: A Retrospective Comparative Study of Factors Influencing Drugs Rejection and Reintroduction in Health Care | | |
Sothuku Shashikanth, Gaddameedhi Arun Jyothi, T Chakradhar, Resu Neha Reddy, Orooj Fathima, Hajra Irshad
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: Comparing the post rejection optimization process, which improves its pharmacokinetic and pharmacodynamic properties to make the drug ideal in health care. Methods and Results: The present study is a retrospective observational comparative study. We are coding few examples of new drug approvals (NDA), which are rejected, and optimization process done afterwards to reintroduce the drug, for example anti-obesity drug rimonabant and inhalational insulin exubera. In case of rimonabant (CB1 receptor antagonist) was withdrawn worldwide in 2008 due to serious psychiatric side effects and various synthetic analogues of same pharmacophore are being developed and screening process is going on. One compound developed by replacement of 4-methyl substituent in rimonabant by a methyl sulfanyl group has increased potency, high CB1 receptor affinity, and high CB1/CB2 receptor selectivity.
In case of exubera there was lack of efficacy and due to bulky device it was discontinued. In 2011 the FDA denied approval of Afrezza (recombinant human insulin dissolved with excipient powder fumaryl diketopiperazine) because the design of the delivery device had changed, the FDA requested additional clinical trials. A phase III study was conducted showing effective drug-device combination product. It uses a different inhaled insulin formulation using technosphere technology. It has more convenient delivery system and greater dosing flexibility compared to exubera. Conclusion: development of ideal compounds from one pharmacophore model with increased potency, receptor affinity, receptor selectivity and choosing ideal drug delivering system with good excipients during drug development can decrease the chances of rejection during clinical trials.
| » CPO-65: Judicial Attribution of an ADR to a Particular Drug | | |
Orooj Fathima, Gaddameedhi Arun Jyothi, T Chakradhar, Hajra Irshad, Sothuku Shashikanth, Nunavath Ravi Naik
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: To analyze the absurd association of an ADR to a particular drug which may have a negative impact on the drug usage in healthcare. Methods: Its a prospective observational study in which 6 ADR's are collected from different departments in a tertiary care centre. The patients under study were using more than one drug and the ADR has been attributed to one drug, while even the other drugs were known to cause the same ADR. Results: Two of the such observed cases are as under: 1. A male,epileptic patient was reported with urticaria and itching who was on levetiracetam, pantoprazole, optineuron and ceftriaxone. The physician has reported the ADR to be due to optineuron, whereas even levetiracetam and ceftriaxone have been reported to cause the same adverse drug reaction .Unless and until a rechallenge is done, the exact drug causing the ADR in a particular patient cannot be known. 2. A male HIV positive patient diagnosed with pulmonary tuberculosis was put on AKT-4 (isoniazid, rifampicin, pyrazinamide and ethambutol) and anti-retroviral therapy which included ziduvidine, lamivudine and nevirapine. He was reported with ADR of chapped lips, the cause for which was attributed to AKT4 while it can be due to the concomitant ART drugs or could be due to the disease itself. Thus a clear association between the drug and ADR is doubtful. Conclusion: An improper and incomplete ADR can have a negative impact on the clinical use of the drug.To overcome this a proper, judicious reporting and vigilance and avoiding incomplete reporting of the case can improve and rule out the gloomy aspects of many useful drugs.
| » CPO-66: Strategy for Therapeutic Drug Monitoring (TDM) and its Implications on Response and Tolerability of Sunitinib in Patients with Metastatic Renal Cell | | |
Nehra J, Sharma J, Patil D, Deshpande R, Patil A, Nookala M, Prabhash K, Joshi A, Gota V
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: The present study was designed to develop a TDM strategy for Sunitinib (SU) in metastatic renal cell carcinoma (mRCC). Methods: Adult patients aged 18 and above receiving SU starting dose of 50 mg OD as first line treatment for mRCC were enrolled in the study. Each cycle comprised of either 4 weeks of treatment with SU followed by 2 weeks rest (4/2) or 2-week on–1-week off (2/1). Response was categorized as Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD) using RECIST 1.1. Toxicity was graded as per CTCAEv4.03. Trough samples for determination of SU and its active metabolite (SU 012662) were collected on cycle 1 at steady state. Drug levels were measured using a validated HPLC assay. Results: 45 patients were enrolled of whom 33 were evaluable for response (PR+SD=26, PD=7) and 39 for toxicity. Trough levels were highly variable (CV = 46%, 60% and 46% for SU, SU 012662 and total drug respectively). Receiver Operating Curve (ROC) characteristics showed that threshold trough concentrations of 80.4ng/mL and 66.35ng/mL of total drug could predict occurrence of Grade-3 toxicity (AUC= 0.829; 95% CI = 0.694-0.964; P=0.001) and best response AUC= 0.797; 95%CI = 0.575- 1.00; P=0.01) respectively. The OR of grade 3 toxicity at the aforementioned threshold was 19.83 (3.44-114.09; P<0.001) and that for best response was 7.33 (1.17-46.05; P=0.04). 2/1 regimen had fewer dose interruptions and delays compared to 4/2 regimen (P<0.05). Conclusion: SU exhibited high pharmacokinetic variability. Trough levels at steady state were highly predictive of Grade-3 toxicity and response suggesting TDM based dosing could significantly reduce the morbidity and improve outcomes of SU treatment. The 2/1 was better tolerated than 4/2 regimen.
| » CPO-67: A New Era for MD Pharmacologists… Are the Winds of Change Finally Blowing Us Where We Belong? | | |
Medhinee Kulkarni1, Kiran Bhave, Prasad R Pandit
Department of Pharmacology, HBTMC and Cooper Hospital, Mumbai, Maharashtra, India
The dilemma faced by freshly passed out post-graduates of MD Pharmacology has recently compounded, owing to the burgeoning opportunities for innovative start-ups and MSMEs, apart from the standard opportunities as Teaching Faculty, and “joining the industry”. However, in either case, the training received in the tenure is never utilized completely. There are opportunities available in the hospitals for these candidates, wherein their area of expertise is completely utilized, with minimal patient contact. It is being described as “Hospital Pharmacologist”, and it is their duty to audit prescriptions, minimize errors, and report adverse drug reactions; as well as taking a more active role in tackling the incidence of hospital acquired infections, designing drug purchase/dispensing for the hospital, and conducting and organizing CME programs for discussion of newly released guidelines, formulation of new SOPs which will benefit the hospital as well as the patients.
| » CPO-68: Clinical Pharmacokinetics of Three-hour Extended Infusion of Meropenem in Adult Patients with Severe Sepsis and Septic Shock: Implications for Targeting Susceptible and Intermediate Strains of Gram Negative Bacteria | | |
Nookala MN, Gota V, Kothekar A1, Myatra SN1, Harish MM1, Suhail SS1, Patil AG, Gurjar M, Biswas S1, JV Divatia1
Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, 1Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre, Tata Memorial Hospital, Mumbai, Maharashtra, India
Introduction: Pharmacokinetics of antibiotics are altered in severe sepsis and sepsis shock. Optimal antibacterial activity of meropenem requires that its plasma concentration (Cp) remains above the minimum inhibitory concentration (MIC) for the pathogen for at least 40% of dosing interval (fT>MIC>40). We determined whether an extended infusion (EI) of Meropenem in patients with severe sepsis or septic shock achieves fT>MIC>40, and whether Cp of meropenem exceeds the MIC within 1 hour of starting infusion. Methodology: Arterial blood samples of 25 patients with severe sepsis or septic shock receiving Meropenem 1 gram as a 3 hour EI every eight hours were obtained at various time intervals during the first and seventh dose. Plasma meropenem concentrations were determined using a reverse phase high-performance liquid chromatography assay, followed by modeling and simulation of pharmacokinetic data. MIC break points for sensitive and resistant bacteria were obtained from the Clinical and Laboratory Standards Institute. Results: EI infusion of Meropenem consistently achieved fT>MIC>40 and Cp > MIC within 1 hour for enterobacteriaceae with break point ≤ 2 μg/mL. However, it failed to achieve fT>MIC>40 in 33% patients for susceptible strains of non-lactose fermenting bacteria (NLFB), [break point 4 μg/mL]. Compartment modeling demonstrated that a dose of 1.5g administered as 3 hr infusion 8 hourly will achieve fT>4μg/mL>40 in 19 out of 20 patients. Conclusion: In patients with severe sepsis or septic shock, EI of 1g meropenem over 3hrs administered 8 hourly was adequate to treat susceptible and intermediate strains of Enterobacteriaceae, but was inadequate for susceptible strains of NLFB.
| » CPO-69: Comparative Study to Evaluate Efficacy and Safety of Azilsartan and Telmisartan in Patients with Grade I–II Essential Hypertension” | | |
Sameer SK, Bhosla DS
Department of Pharmacology, MGM Medical College and Hospital, MGM Univeristy, Aurangabad, Maharashtra, India
E-mail: [email protected]
Objectives: To study the effect of Azilsartan 40 mg once daily versus Telmisartan 40 mg once daily in patients with Grade I–II essential hypertension. Materials and Methods: A prospective study was conducted at MGM Medical college and Hospital which included 80 patients in each group with Grade I–II essential hypertension. The sex, age, presenting illness, and family history of the patients were recorded. Investigations such as blood sugar, urine analysis, kidney function test, lipid profile, and ECG were performed before starting the treatment. Any adverse effects during the treatment were noted. Blood pressure was recorded at baseline and during follow-up. One group received Azilsartan 40 mg once daily and other group Telmisartan 40 mg once daily. Patients were followed-up every week for 5 weeks. Results: Patients receiving Azilsartan 40 mg and Telmisartan 40 mg showed a significant fall (P <0.05) in systolic (SBP) at the end of fifth week, when compared to baseline and diastolic blood pressure (DBP) significant fall at fourth and fifth week. The difference in fall in SBP and DBP was insignificant between the groups, after first, second and third week (P >0.05). Adverse effects such as Nasopharyngitis, Upper respiratory tract inflammation, Gastroenteritis, headache, dizziness, and fatigue were reported with both drugs. Conclusion: Reduction of blood pressure with Azilsartan and Telmisartan was similar, but fall in blood pressure from baseline was highly significant in both groups.
| » CPO-70: Lamotrigine Monotherapy and Sleep Quality in Epileptic Patients with Generalised Tonic-clonic Seizure: A Prospective Study | | |
Kumar A, Gupta MC
Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India
E-mail: [email protected]
Objective: The older antiepileptic drugs (AEDs) have a variety of effects on sleep, including reduction in REM, slow wave sleep (SWS) and increased percentage of light sleep. On the literature search, few studies have reported the influences of lamotrigine (LTG) as add on drug to the conventional first line AEDs. Our purpose was to evaluate the effects of LTG as monotherapy in epileptic patients on quality of sleep by using polysomnography (PSG). Methods: 30 patients were included in cross over fashion and were subjected to PSG to have their baseline data. After recording the baseline data, all the patients were given LTG monotherapy. Patients were assessed for a period of 3 month for control of seizures. The patients in whome seizures were controlled were subjected to PSG at the end of 3 months and observations were compared with baseline data using student paired t-test. Results: 8 out of 30 patients were titrated to an LTG dose of 200 mg/day. Treatment with LTG produced a significant decrease in SWS, an increase in stage 2 sleep percentages and non-significant increase in REM sleep. No significant difference in any of the other polysomnographic variables. No patients reported insomnia with treatment. Conclusion: LTG appears to be less disruptive to sleep quality than some of the older AEDs.
| » Central Nervous System Oral | | |
| » CNSO-1: Evaluation of Anxiolytic Activity of Leaves of Moringa Oleifera in Albino Rats | | |
Lahon A, Das SM
Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam, India
E-mail: [email protected]
Objective: To study the anxiolytic effect of leaves of Moringa Oleifera in albino rats. Materials and Methods: The experiment were carried out on 20 Albino rats of either sex with ethanol extract of leaves of Moringa Oleifera (EEMO). The rats were divided into four groups. Group 1 served as a control & received normal saline intraperitoneally (I.P). Group 2 (standard) received diazepam 2mg/kg body weight I.P. Group 3 & 4 received 200 mg/kg & 400 mg/kg body weight of EEMO intraperitoneally. The rats were subjected to elevated plus maze test & mirrored chamber test. The preference of first entry, number of entries & time spent in open & closed arms were recorded in elevated plus maze test. While in mirrored chamber test the latency to enter, number of entries & total time spent in the chamber were recorded. The data were analysed & tabulated statistically. Results: It was seen that 400 mg/kg of EEMO were effective as anxiolytic. The number of entries, latency to enter & time spent in the test groups were as close as to the standard group. Conclusion: The present study suggest that the leaves of Moringa Oleifera in high dose is effective as anxiolytic in rats.
| » CNSO-2: Involvement of Opioid and Monoaminergic Pain Pathways in Aloe Vera Induced Analgesia. An Experimental Study | | |
Senapaty S, Suman RK, Shahani S
Department of Pharmacology, MGM Medical College, Navi Mumbai,
E-mail: [email protected]
Objective: To determine the antinociceptive activity of aqueous extract of aloe vera (AqEAV) and to investigate the role of opioid and monoaminergic pain pathways in aloe vera induced analgesia in rats. Materials and Methods: Analgesic activity of AqEAV (100, 200 and 400 mg/kg orally) was studied using tail flick test and acetic acid induced writhing in rats. Thereafter, the subeffective dose of AqEAV was combined with subeffective doses of pentazocine and venlafaxine separately. The effect of pretreatment with opioid antagonist naltrexone 1 mg/kg was also studied. Results: AqEAV at a dose of 400mg/kg produced significant (p<0.05) antinociceptive activity in tail flick test and acetic acid induced writhing in rats which is suggestive of possible central as well as peripheral action. The effect of combined treatment in subanalgesic doses also demonstrated significant antinociception (p< 0.05) This suggests synergistic action between the drugs indicating the involvement of opioid receptors, serotonergic and noradrenergic systems (descending pathway) in the pain pathway. Pretreatment with naltrexone inhibited antinociceptive activity induced by AqEAV alone and combination with pentazocine or venlafaxine. This further confirmed the involvement of opioid receptors in the pain reducing mechanism of AqEAV. Conclusion: Both opioid and monoaminergic pain mechanisms are involved in AqEAV induced analgesia in rats. Therefore aqueous extract of aloe vera could be used for the treatment of neuropathic pain and chronic pain conditions.
Keywords: Aloe vera, analgesia, monoamines, opioid
| » CNSO-3: Interaction between Dietary and Environmental Factors in the Induction of Dementia: A Preclinical Evaluation | | |
Kishore A, Nampoothiri MG, Jose S, Krishnadas N, Nayak PG
Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
E-mail: [email protected]
Background: Dietary factors and environmental toxins are some of the predisposing influences of dementia. However, the interaction between these factors leading to dementia is poorly understood. So, we conducted an experiment to study the combined effect of two separate pathophysiological mechanisms (viz. dietary factors and environmental toxins) that lead to dementia. Objective: To evaluate the effect of a dietary factor (a high-fat diet, HFD) on the induction of memory impairment, in an environmental toxin (aluminium chloride, AlCl3) induced mouse model of dementia. Further, we examined the behavioural and biochemical effects of HFD and AlCl3 treatment in the model. Methods: Four weeks old mice were randomized into the following groups: Normal control, AlCl3 treated for four months, HFD fed for four months, and HFD fed for four months with AlCl3 treatment for last two months. In the animals, spatial learning and memory was assessed by water maze test. Also, the serum levels of glucose, total cholesterol and triglycerides were estimated. Results: The combination of HFD+ AlCl3 showed aggravated decline in learning and memory compared to AlCl3 alone treated group. Significantly elevated glucose, cholesterol and triglycerides level were observed in HFD+ AlCl3 treated mice. Conclusion: In summary, cognitive dysfunction was evident in four months HFD fed animals when simultaneously treated with AlCl3 for two months. The possible mechanisms may be deranged glucose metabolism and lipid homeostasis caused by HFD and neuro-biochemical changes induced by AlCl3.
| » CNSO-4: Pharmacodynamic and Pharmacokinetic Studies of Developed Intranasal Formulation of Mirtazapine | | |
Kadam P, Suares D
Department of Pharmaceutics, Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS Deemed-to-be-University, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Mirtazapine, an antidepressant, gets extensively metabolized during first-pass metabolism. In order to evade its gastrointestinal burden and enzymatic degradation, intranasal drug delivery approach is desirable which enables the drug to reach systemic circulation directly through the nasal mucosa providing an immediate release system and dose reduction. Methods: Nanostructured lipid carrier (NLC) formulation of Mirtazapine was developed by solvent emulsification diffusion technique. NLC's were characterized for particle size, zeta potential, drug content, entrapment efficiency and in vitro drug diffusion studies. The pharmacodynamic study of developed nano-formulation was evaluated in Wistar rats by tail suspension method. The groups studied included Control, API suspension (6 mg/kg, p.o.), Placebo nanoformulation (Intranasal) and Mirtazapine-loaded nanoformulation (6mg/kg, intranasal), respectively. In addition to this, pharmacokinetic study was carried out in Wistar rats and blood was withdrawn at 5min, 15min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h and 4h. Results: Developed NLC formulation of Mirtazapine showed particle size in the range of 400-800 nm, zeta potential of -25 to -38 mV, drug content of 98-100%w/v, entrapment efficiency of 60-70%w/v and drug release of approx. 84%w/v in 6h. Pharmacodynamic studies revealed that Mirtazapine-loaded NLC (intranasal) showed significant change (p<0.05) in behavioural activity and significant increase (p<0.0001) in the immobilization period as compared to oral, placebo and control groups. In pharmacokinetic study, Mirtazapine-loaded NLC formulation showed an average Cmax of 27±8.4ng/mL in the initial 5 min for immediate action. Conclusion: Developed Mirtazapine-loaded NLC was found to be suitable for intranasal delivery of Mirtazapine for immediate action.
| » CNSO-5: Evaluation of Hesperetin Against 3-nitroprioponic Acid Induced Huntington's disease Like Symptoms in Rodents | | |
E Nagarjuna Babu, A Prameela Rani
University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India
E-mail: [email protected]
Oxidative stress (OS) and nitric oxide mechanisms have been recently proposed in 3-nitropropionic acid (3-NP)-induced neurotoxicity. The compounds, having antioxidant, anti-inflammatory and neuroprotective effects, have been suggested for neuroprotection in different experimental models. Flavonoids are known by their antioxidant activities thus preventing oxidative stress, which is believe to be one of the causes of disorders affecting the central nervous system. Hesperetin is a derivative of flavonoid reported to have a variety of biological activities, including anticancer, antiviral, antioxidant, neuroprotective and anti-inflammatory properties. Hence, the present study was designed to evaluate the neuroprotective effect of Hesperetin on 3-NP-induced neurotoxicity in rats by observing behavioral changes, OS and striatal damage in rat brain. Adult male Wistar rats were pretreated with vehicle or Hesperetin (25 and 50 mg/kg) for 7 days, followed by cotreatment with 3-NP (15 mg/kg, intraperitoneally) for the next 7 days. At the end of the treatment schedule, rats were evaluated for alterations in sensory motor functions and short-term memory. Animals were sacrificed and brain homogenates were used for the estimation of lipid peroxidation (LPO), Reduced glutathione, catalase and Superoxide dismutase (SOD) and enzyme estimations Succinate dehydrogenase (SDH), Acetyl cholinesterase enzyme activity (AchE) and Neurochemical estimations GABA and Glutamate. A set of brain slices was used for the evaluation of neuronal damage in the striatal region of the brain. 3-NP caused significant alterations in animal behavior, oxidative defense system evidenced by raised levels of LPO and enzyme levels, and depletion of antioxidant levels. It also produced a loss of neuronal cells in the striatal region. Treatment with Hesperetin significantly attenuated behavioral alterations, oxidative damage and striatal neuronal loss in 3-NP-treated animals. The present study shows that Hesperetin is protective against 3-NP-induced neurotoxicity in rats. The antioxidant, anti-inflammatory and neuroprotective properties of Hesperetin may be responsible for its neuroprotective action.
| » CNSO-6: Neuroprotective Potential of Resveratrol against Recurrent Stroke: Putative Role of Oxidative Stress and SIRT1 | | |
Rajeev Taliyan, Sruthi Ramagiri, Violina kakoty
Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Rajasthan, India
Introduction: Cerebral ischemic reperfusion (I/R) injury is one of the leading cause of death worldwide. It is characterized by energy failure, neuroinflammation, excitotoxicity ultimately leading to epigenetic modifications. Recent studies highlighted the beneficial role of nicotinamide adenine dinucleotide (NAD) dependent deacylases sirtuins (SIRT1) in various neurodegenerative disorders. However, the epigenetic modifications by SIRT1 during cerebral I/R injury remains to be elucidated. Materials and Methods: Rats were subjected to cerebral I/R injury by occlusion of common carotid artery with 20 min of ischemia followed by 7 days of reperfusion. In another group, following cerebral I/R injury rats were treated with SIRT1 activator, resveratrol (10 mg/kg, i.p.) immediately after reperfusion and continued till 7 days with 24 hours interval. Cognitive impairment was assessed by Y-maze and passive avoidance. Further, a battery of biochemical and histological tests were performed to evaluate oxidative stress and hippocampal healthy neuronal count. Results: Cerebral I/R injury resulted in severe oxido-nitrosative stress and markedly decreased anti-oxidants like GSH and SOD. Cerebral I/R injury induced neuroinflammation was evidenced by increased levels of TNF-α and IL-6. Cognitive impairment induced by cerebral I/R injury was indicated by reduced spontaneous alterations and decreased retention latency in Y-maze and passive avoidance task respectively. Further, the memory loss was well correlated with hippocampal damage as evidenced by increased pyknotic neuronal count. However, treatment with resveratrol reduced the oxidative stress, neuroinflammation, hippocampal damage along with improvement in cognitive performance. Conclusion: Based on the results, it can be suggested that resveratrol attenuated oxidative and neuro-inflammation and hippocampus damage via increasing SIRT1 levels. Thus, SIRT 1 play an important role in resveratrol neuroprotection against cerebral I/R injury and associated cognitive impairments.
| » Cardiovascular System Oral | | |
| » CVSO-1: To Evaluate the Effect of Olmesartan on Blood Glucose Levels and Blood Lipid Levels in Streptozotocin Induced Diabetic Rats | | |
Siddamma Amoghimath, Suresha RN1
Gadag Institute of Medical Sciences, Gadag, 1JSS Medical College, Mysuru, Karnataka, India
E-mail: [email protected]
Objective: To evaluate the effect of Olmesartan on blood glucose levels and blood lipid levels in streptozotocin induced diabetic rats. Methods: Eighteen Wistar albino rats weighing 150-200gms of either sex were randomly selected from the central animal facility, and divided into 3 groups. Diabetes was induced by injecting Streptozotocin intraperitonelly. The control group received 1% Gum acacia(oral), standard group received 0.5 mg/kg Glibenclamide (oral) and the test group received Olmesartan 3.6mg/kg body weight (oral) from 0-28 days respectively. Body weight of the individual rats were measured on the respective days before blood glucose estimation on 0, 1, 3, 7, 14, 21 & 28th day and fasting blood glucose was estimated by (ACCUCHECK) glucometer. Estimation of fasting lipid profile by lipid screening strips on 1st and 28th day. Results: The blood glucose levels in the Olmesartan group was less when compared to the control group at all the intervals but comparable with that of standard drug Glibenclamide in Streptozotocin induced diabetic rats. The Olmesartan group showed improved lipid profile when compared to control group in Streptozotocin induced diabetic rats. Conclusion: Olmesartan showed hypoglycemic activity and improved lipid profile action which is comparable to standard drug glibenclamide in Streptozotocin induced diabetic albino rats.
| » CVSO-2: Comparative Study of the Efficacy and Safety of Rosuvastatin 5mg Daily Versus Rosuvastatin 10mg Alternate Day for Dyslipidemia | | |
Arikeri Vasu Deva Rao, Raju devde, Imran Khan
Kakatiya Medical College, Warangal Telangana, India
E-mail: [email protected]
Objectives: To compare the change in lipid profile from baseline to the end of the study between daily dosing Rosuvastatin 5 mg versus alternate day Rosuvastatin 10 mg and to document the adverse drug effects of Rosuvastatin. Methods: 60 patients with dyslipidemia who fulfilled the eligibility criteria and had willing to give informed consent were included in the study after getting IEC approval. Patients were divided into 2 groups A & B of 30 each. Initially, patients in group A were treated with Tablet Rosuvastatin 5 mg daily and group B were treated with Rosuvastatin 10 mg alternate day for 6 months. Lipid profile was recorded. After a wash out period of 2 weeks, patients of Group A were treated with tablet Rosuvastatin 10mg alternate day and patients of Group B were treated with tablet Rosuvastatin 5 mg daily for a period of 6 months and laboratory parameters like lipid profile, LFT & CK were performed. Appropriate statistical methods were used to analyze the results. Results: In our study at the end of study period of 1 year, there was a significant reduction of TC,LDL-C, TG, TL/HDL ratio, LDL/HDL ratio by 18.53%,32.97%, 25.32%,19.39%,37.13% in patients of group A and in group B was by 25.51%,37.58%, 27.32%,17.21%31.76% respectively. HDL-C was significantly increased by 8.97% in group A and by 6.14% in group B. Conclusion: In our study we observed a significant reduction of TC, LDL-C, TC/HDL ratio and LDL/HDL ratio with Rosuvastatin 10 mg alternate day in group A and group B at the end of 12 months when compared with baseline values. Though being well tolerated mild unwanted effects including myalgia, GI disturbance, raised LFT, headache and insomnia were among the most frequently reported adverse effects.
Keywords: Dyslipidemia, rosuvastatin
| » CVSO-3: Effect of Fluoxetine and Escitalopram on Heart Rate Variability and Serum Potassium Level in Patients of Depression and Anxiety Disorders | | |
Machhi TR, Kantharia ND
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
E-mail: [email protected]
Objective: Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is a very important indicator of cardiac autonomic regulation. The study was conducted to assess the effect of Fluoxetine and Escitalopram on HRV and serum potassium level because the relationship of baseline HRV to treatment outcome and its association with serum potassium level in these disorders are unclear. Methods: This continuous interventional and single centre study was conducted in 70 newly diagnosed patients of depression and anxiety disorders according to diagnostic and statistical manual of mental disorders-4-text revised (DSM-4-TR) criteria. Patients were divided into Fluoxetine and Escitalopram groups (n=35). HRV and serum potassium level were measured four times, first at the first visit and then at 4, 8 and 12 weeks interval. HRV was recorded by Digital Physiopac Polygraph software and data were analysed by appropriate statistical test. Results: Our results showed that Fluoxetine in comparison to Escitalopram showed more significant increase in heart rate variability and both the drugs have no significant effect on serum potassium, respiratory rate, heart rate and blood pressure. Conclusions: In this study, treatment with Fluoxetine and Escitalopram in patients of depression and anxiety disorders significantly improved HRV but have no effect on serum potassium, heart rate, respiratory rate and blood pressure.
| » CVSO-4: A Cross-sectional Study to Evaluate the Potential Drug-drug Interactions among Ischemic Heart Disease Patients at a Tertiary Care Hospital” | | |
Praveen AN, Vijayalakshmi
Department of Pharmacology, Bangalore Medical College and Research Institute, RGUHS, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: To evaluate the potential drug-drug interactions (pDDI) in patients with ischemic heart disease (IHD). Methods: An analytical cross-sectional study conducted from March 2017 - October 2017 to analyze the pDDIs among the out-patients of Cardiology department at BMCRI. All the patients with IHD on at least two drugs were enrolled. Patient demographic data and prescription details (drugs prescribed, duration of therapy and number of drugs) were collected in a case record form. Drug data was analyzed for interactions using the standard drug interaction software (Lexicomp version 4.1.1) by Risk rating scale (assigned A, B, C, D or X). Monographs rated C, D or X always requires the clinician attention. Results: Among 520 enrolled IHD patients, 489 patients had 3217 pDDIs. Average number of drugs prescribed per patient was 6.4+1.6 and the most commonly prescribed drugs were Aspirin (93%), Atorvastatin (88%), Clopidogrel (60%), metoprolol (57%) and Ramipril (43%). Aspirin and Clopidogrel (54%), Atorvastatin and Clopidogrel (53%), Aspirin and Ramipril (40%) were the most commonly interacting pairs. Majority of interactions were of moderate category (2465; Risk Rating C) which require monitoring of therapy. Conclusion: Antiplatelets and statins were the most commonly prescribed drugs in IHD and contribute to most of the pDDIs in particular category C and D. Awareness regarding these pDDIs should be raised among prescribers which will enable them to recognize drug combinations leading to potential adverse effects and avoid them or to monitor therapy if such drugs are deemed essential.
| » CVSO-5: Prescribing Patterns and Cost of Antihypertensive Prescribed in Cardiology Dept: A Tertiary Care Experience | | |
Mishra V, Swain TR, Mishra CK, Samal R, Mohanty S
Department of Pharmacology, Sriram Chandra Bhanj Medical College and Hospital, Utkal University, Cuttack, Odisha, India
E-mail: [email protected]
Objectives: 1. To assess the prescribing patterns for Antihypertensive. 2. To analyse the factors that is responsible for Antihypertensive prescribing behaviour of physicians in a tertiary care hospital. Methods: A Prospective observational study was carried out for the period of six months in the Cardiology out-patient department of SCB Medical College, Cuttack, Odisha. Patients with BP ≥140/90 mmHg attending cardiology OPD and willing to participate in the study were included. Demographic profile, clinical (general and systemic) examination, basic laboratory investigations was collected and entered in a specially designed case record form. Results: A total of 80 prescriptions were analyzed during the six-month study period. 63 were male (78.75%) and rest 17(67.5%) were female. 37(46.25%) patients were more than 60 years and rest 43(53.75%) patients aged below 60 years. Polytherapy is more common practice than monotherapy. 33 patients (41.25%) underwent monotherapy treatment and the rest 47(58.75%) patients underwent multitherapy treatment. Total 27(25.47%) patients were prescribed Metoprolol and 22 (20.08%) patients were prescribed Telmisartan and 17 (16.06%) patients were prescribed Olmesartan. 31 (38.75%) patients were given fixed dose combination drugs. Conclusion: This study showed that the Telmisartan followed by Olmesartan and Metoprolol were most commonly prescribed with or without other drugs. Underutilization of diuretics and inadequate oral instructions are limitations of the present prescribing pattern.
Keywords: ARBs, azilsartan, hypertension
| » CVSO-7: Natural Dipeptidyl Peptidase-4 Inhibitor Terminalia arjuna Mitigates Myocardial Injury in Experimental Model of Myocardial Infarction Co-existing with Diabetes | | |
Borde MK, Mohanty IR1, Maheshwari U1, Suman RA2, Deshmukh YA1
Department of Pharmacology Sinhgad Dental College and Hospital, Pune, 1Department of Pharmacology, Pathology, MGM Medical College, Navi Mumbai, Maharashtra, 2Department of Pharmacology, Hind Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
Objective: The present study was designed to evaluate the cardio-protective effects of Terminalia arjuna in an experimental model of diabetes co-existing with myocardial infarction. In addition, safety and the underlying mechanisms for its beneficial effects were also delineated. Methods: Necessary approval from the Institutional Animal Ethics Committee was taken for the study. Diabetes was induced with Streptozotocin: 45mg/kg ip and myocardial infarction was produced by administering Isoproterenol: 85mg/kg, sc to rats 24 and 48 h prior to scarification (5th week). After the confirmation of diabetes on 7th day (Glucose >200mg/dl), Terminalia arjuna (500 mg/kg) was orally fed to the experimental rats for 4 weeks. Various parameters like anti-diabetic, cardioprotective, antiinflammatory, antioxidant, alter lipid metabolism, DPP-4 pathway, safety {pancreas, liver and kidney function}, anti-apoptotic and histopathological indices of injury were evaluated in experimental groups. Results: Terminalia arjuna (500 mg/kg) treatment demonstrated significant antidiabetic as well as myocardial salvaging effects as indicated by biochemical; diabetes [significant reduction in blood glucose, HbA1c (p<0.001)], cardiac [reduction in CPK-MB (p<0.001)] as compared to Diabetic- ISP Controlgroup. In addition, it favorably modulated the lipid metabolism [decreased TG,TC, LDL-C, increased HDL-C (p<0.001) and atherogenic index (p<0.001)], DPP-4 pathway [reduced serum DPP-4 level (p<0.001)], antioxidant [ reduced Lipid peroxidation (p<0.05)], inflammatory marker [decreased hs-CRP (p<0.01)] and anti-apoptotic [TUNEL assay (p<0.001)]. Histopathological and biochemical markers of injury confirmed the safety of Terminalia arjuna on the pancreatic, hepatic and renal functions. Conclusion: Terminalia arjuna demonstrated significant cardioprotective effects in experimental model of myocardial infarction co-existing with diabetes. Myocardial salvaging effects of Terminalia arjuna may be attributed to several mechanisms (DPP-4 inhibition, hypolipidemic, reduced atherogenic potential, anti-inflammatory, antioxidant and anti-apoptotic activities).
| » CVSO-8: Effect of Single Dose 10 mg Cilnidipine Tablet on Orocecal Transit Time in Healthy Human Subjects | | |
Bisoi D, Nutalapati C, Pingali U
Department of Clinical Pharmacology and Therapeutics, NIMS, Hyderabad, Hyderabad, India
E-mail: [email protected]
Objectives: Orocecal transit time (OCTT) is the time required for transit of food from oral cavity to caecum (275-347minutes). Sulfasalazine method is a noninvasive validated method for measuring OCTT. Calcium Chanel Blockers (CCBs) act by relaxing smooth muscle of the arterial wall and of a number of other organs like intestinal smooth muscle. Literature of its activity on small bowel function and OCTT in humans is few and inconclusive. The present study was done to evaluate the effect of cilnidipine, a CCB on OCTT in healthy subjects. Methods: After ethics committee approval and obtaining written informed consent, 12 healthy adult male subjects mean age 33.75±3.9 years participated in this study. They were randomized to either cilnidipine or identical placebo in double blinded manner. Under fasting, subjects were administered either cilnidipine 10 mg tablet or identical placebo half-an-hour before administering 2gm sulfasalazine. Salivary samples were collected at 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10hrs of sulfasalazine administration in both groups. After 7 days washout period, subjects were crossed over to receive the other formulation and the same procedure was repeated. The salivary samples were analyzed by Bratton and Marshall Method (diazotization). Data are presented as Mean ± SD. Paired t-test was used for analysis. Results: There was a significant increase in the mean OCTT with Cilnidipine 10 mg (432.54 ± 15.44minutes) compared to placebo (350± 19.54minutes) (p<0.001). No adverse drug reactions were observed. Conclusions: Cilnidipine increased mean OCTT in normal healthy subjects suggesting that it may delay gastric emptying. This may impair absorption or augment gastrointestinal inhibitory effect of other concomitantly administered medications and cause symptoms related to delayed gastric emptying or gastroesophageal reflux. Further studies on patients needs to done to confirm this.
Keywords: Bratton and marshall method, calcium channel blockers, orocecal transit time
| » Drug Discovery And Development Oral | | |
| » DDDEO-1: To Evaluate Effect of Ethanolic Extract of Leaves Holoptelea integrifolia on Blood Glucose Levels in Euglycemic Albino Rats and Diabetic Rats | | |
Ranjith Raj, Jayanthi MK
Department of Pharmacology, JSS Medical College, JSS University, Mysuru, Karnataka, India
E-mail: [email protected]
Objective: 1. To evaluate effect EELHI on blood glucose levels in Euglycemic rats through OGTT. 2. To assess effect on blood glucose & to compare activity of EELHI in streptozotocin induced diabetic rats. Methods: To study the blood glucose effect of extract, two models, namely, non-diabetic (OGTT) and streptozotocin induced diabetes were utilized. A total of 36 rats were divided into two groups of 18 each to be utilized for the two models. Further within each model, animals were randomly allocated to 3 groups of 6 rats each. Group1-control (gum acacia), Group2-standard drug (Glibenclamide dose of 0.5mg/kg/bw), Group 3- test drug (EELHI at 200 mg/kg conc). All drugs given orally for 5 days in non-diabetic group(OGTT) & 28 days in diabetic groups, blood glucose level was analysed using glucometer at 0, 60 & 150min in non-diabetic groups & on Day 0, 1, 2, 3, 7, 14, 21 & 28 in diabetic & control groups results were analysed by ANOVA and Tukey's Post Hoc test. Results: EELHI showed hypoglycaemic action in streptozotocin induced diabetic rats. It did not produce hypoglycaemia in non-diabetic rats. Hypoglycaemic action of EELHI is comparable to that of standard oral hypoglycaemic drug glibenclamide. Conclusion: Our study demonstrates the hypoglycaemic action of EELHI in diabetic rats and no hypoglycaemic activity in non-diabetic rats, which is an added advantage over conventional anti-diabetic drugs which are known to cause hypoglycaemia as an added adverse effect. EELHI can be a therapeutic potential to treat type II DM.
| » DDDEO-2: Preclinical Evaluation of Anticonvulsant Activity of Ethanolic Extract of Crocus sativus in Albino Rats | | |
Priyanka CA, Jayanthi MK
Department of Pharmacology, JSS Medical College, JSS University, Mysuru, Karnataka, India
E-mail: [email protected]
Objective: To evaluate the antiepileptic activity of ethanolic extract of Crocus sativus (EECS) in albino rats. To compare the antiepileptic effect of combination of EECS and valproic acid with either drug alone. Methods: Albino Wistar rats of either sex weighing 150 to 230 g were divided into 4 groups of 6 rats each. Control group treated with propylene glycol 0.5ml orally, Standard group received 200 mg/kg Valproic acid orally. Test 1- received 200 mg/kg of EECS orally. Test 2- received with 100 mg/kg of EECS orally + 100 mg/kg Valproic acid. Anticonvulsant profile was evaluated in two conventional experimental models of epilepsy: The Maximal Electroshock Seizure (MES) test and the Pentylenetetrazole (PTZ)-induced seizure test in albino Wistar rats. The results were analyzed by ANOVA followed by Tukeys multiple comparison test. Results: EECS showed significant anti-epileptic property in both MES and PTZ induced seizure models. There was a significant abolition of tonic hind limb extension phase in MES model and increase in seizure latency period in PTZ induced seizure model. Conclusion: Ethanolic extract of crocus sativus can be a promising anti-epileptic agent beneficial in both absence and tonic clonic seizures.
| » DDDEO-3: Preclinical Evaluation of Diuretic Activity of Methanolic Extract of Seeds of Artocarpus heterophyllus (Jack fruit) in Wistar Albino Rats | | |
Aswathi k, Jayanthi.M.K
Department of Pharmacology, JSS Medical College, JSS University, Mysuru, Karnataka, India
E-mail: [email protected]
Objectives: Evaluation of diuretic activity of methanolic extract of seeds of Artocarpus heterophyllus (Jack fruit). Methods: To evaluate the diuretic property of Methanolic extract of seeds of Artocarpus heterophyllus (Jack fruit) in Wistar albino rats. Total of 24 Albino Wistar rats of either sex weighing 150 to 250 gm were divided into 4 groups of 6 each. I Group: Control (normal saline 10 ml /kg). II Group Standard drug (furosemide 20mg/kg). III Group: Test 1 (MEAH 200 mg/kg). IV Group: T2 (MEAH 400 mg/kg per). Drugs were administered per orally to the animals overnight fasting and subsequently animals were kept fasting during the experiment. Following drug administration, animals were immediately placed in diuretic cages for 24 hours at the end of 24 hours, collected urine was measured and was analysed for various electrolytes.Lipschitz method was used for evaluating the diuretic activity and diuretic index. The results were analyzed by calculating the standard errors, one way analysis and two way analysis (ANOVA). Post-hoc comparisons were performed by applying appropriate test. Results: Results suggest Methanolic extract of seeds of Artocarpus heterophyllus has shown significant increase in diuretic activity at a higher dose. Conclusion: Methanolic extract of seeds of Artocarpus heterophyllus can be projected as a good therapeutic adjuvant along with conventional diuretics.
| » DDDEO-4: Pharmacoeconomic Analysis of Antihypertensive Drugs and Evaluation of Quality of Life of Patients on Antihypertensive Drug Therapy” | | |
DB Chetan1,2, Sujat SP1,2, Wari UG1,2, K Lakshminarayana1,2
1Vijayanagar Institute of Medical Sciences, Ballari, 2Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Introduction: Cost effective management of hypertension appears to be a great challenge globally. Even though there have been studies on pharmacoeconomics and outcome research, but the results cannot be exactly extrapolated to Indian scenario as the economic status and socioeconomic factors are different in India.Hence a study was done to evaluate the cost effective antihypertensive drugs in our hospital. Objectives: To evaluate the prescription pattern, cost effective antihypertensive therapy and Quality of Life (QoL) of the patients.
Materials and Methods: An observational comparative study is planned on 100 patients attending the OPD from Aug 2016 to Jan 2017 with a follow up period of 6 months.In first visit, after obtaining written informed consent,a detailed history regarding the socioeconomic status, disease profile and drug therapy like pattern (mono/multidrug therapy),costs and dosage of the drug with reduction in BP noted. After 6 months, same details are collected with QoL (SF-36 questionnaire).The data so obtained is statistically (Chi Square Test and “T” test) analysed to get results. Results: Multitherapy was frequently prescribed (74%) than monotherapy, out of which Atenolol with Amlodipine combination was most common (54%).In multitherapy Amlodipine with Enalaprill combination was more cost effective[Cost Effective Ratio (CER) 18.24] than Amlodipine with Atenolol (CER 27.73) [p-0.057].In mono therapy Amlodipine proved to be more cost effective(CER 8.93) than Atenolol (CER 26.15) [ p -0.0059]. Conclusion: Multitherapy was most frequently prescribed and Amlodipine with Enalapril combination proved to be most cost effective. No significant difference in HRQoL (Health Related QoL) in all treatment groups.
| » DDDEO-5: Evaluation of Citrus limon Leaf Extract for Anti Anxiety Effect on Elevated Plus Maze | | |
Dr. Godella V, Usha Shree TS
Department of Pharmacology, Gandhi Medical College, Secunderabad, Telangana, India
E-mail: [email protected]
Aims and Objectives: To evaluate anxiolytic activity of ethanolic extract of Citrus Limon leaves on rats. Materials and Methods: A total of 30 rats are grouped into 5 with 6 rats each.Group I(control) received distilled water.Group II(standard)Diazepam 2mg/kg is given.Group III -50mg/kg,group IV-100mg/kg,group V- 200mg/kg of extract is given.Instrument used was Elevated Plus Maze. Data analyzed by one way ANOVA and Post hoc comparisions were performed by Tukey Kramer multiple comparision test. P< 0.05 was considered significant. Results: Ethanolic extract of Citrus Limon in dose of 100mg/kg showed effective anxiolytic activity and was found to be similar to Diazepam. Conclusion: The present study suggest that Citrus Limon may be developed as a potential anti anxiety agent.
Keywords: Anxiety, Citrus limon, diazepam, elevated plus maze
| » DDDEO-6: Evaluation of Anxiolytic Activity of Trachyspermum Ammi (Ajwain oil) in Swiss Albino Mice | | |
Latha S, Jyothi CH
Department of Pharmacology, JJM Medical College, Davangere, Karnataka, India
E-mail: [email protected]
Objective: To evaluate anxiolytic activity of Ajwain oil alone & as combination of subthreshold doses of Diazepam + Ajwain oil, in swiss albino mice. Methodolgy: Total of 24 animals of either sex weighing 20-30g (obtained from the animal house attached to JJM Medical College, Davangere) was included in the study & was divided into 4 groups of 6 animals each. Where, Group 1(control) – tween 80 (10mg/kg), group 2 (standard) – Diazepam (1mg/kg), group 3 (test-1) - Ajwain oil (50mg/kg) Group 4 (test-2) – Diazepam (0.5mg/kg) + Ajwain oil (25mg/kg). After 60min of oral administration of drugs, anxiolytic activity was analysed using Elevated plus maze (EPM) & Digital Actophometer. Results: Statistical analysis was done by ANOVA, followed by post hoc tukey's test. Ajwain oil showed significant increase in time spent and number of entries in open arm & decrease in locomotor activity when compared to control. In group 4, were we used subthreshold dose of Ajwain oil and diazepam, number of entries in EPM & decrease in locomotor activity in Actophotometer showed significant results when compared to standard. Conclusion: Hence with the above results, we conclude Ajwain oil possesses significant anxiolytic activity.
Keywords: Ajwain oil, antianxiety activity, diazepam
| » DDDEO-7: Evaluation of Rationality of Fixed Dose Combinations of Antimicrobials Available in Indian Market | | |
Srivastava Rohan*, Kantharia ND
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
E-mail: [email protected]
Objective: The antimicrobial resistance is alarming at present. One of the important factors for resistance is use of irrational fixed dose combinations (FDCs). Thus, objective was to critically analyze the rationality of FDCs of antimicrobial agents (AMAs) currently available in India. Methods: The FDCs of AMAs enlisted in Indian Drug Review 2017 were analyzed by 8 point criteria tool. Analysis includes number of active pharmacological ingredients, approval by Central Drug Standard Control Organization (CDSCO), listing in World Health Organization (WHO) Model List of Essential Medicines (2017) or Government of India National List of Essential Medicines (2015). Literature search was used for assessing efficacy, safety, pharmacokinetic and pharmacodynamic interactions and advantages of each FDC. Each criterion was assigned score one, if positive and minus one, if negative leading to total score of 12. FDC with score of ≥7 was considered as rational. Results: The FDCs of AMA available in Indian market were 116 while FDCs included in WHO model list, 2017 were 24. Majority of FDCs available were irrational that include combination of antibacterial with bromhexine, carbocisteine, ambroxol, serratiopeptidase, antiamoebic and antifungal etc. Most of the rational FDCs belong to antiretroviral, antitubercular and antimalarial drugs. Conclusion: Most of the FDCs of AMAs available in Indian market are irrational. This needs educating the prescribers including resident doctors. There is need to critically review such FDCs by drug regulators with strict action regarding manufacturing and marketing.
| » DDDEO-8: Effect of Pyridostigmine on Blood Glucose Levels in Euglycemic Rats | | |
S Amoghimath, Shruthi SL, Suresha RN
1Gadag Institute of Medical Sciences, Gadag, 2Shimoga Institute of Medical Sciences, Shimoga, 3JSS Medical College, Mysuru, Karnataka, India
E-mail: [email protected]
Objective: To study the effect of Pyridostigmine on blood glucose levels in euglycemic albino rats through Oral Glucose Tolerence Test. Methods: 12 Wistar albino rats of either sex of average weight 150-200gms aged 3-4 months were used in the experiments and the rats were divided into 2 groups containing six animals (n=6) in each group (control and test group). The control group received distilled water (25ml/kg body wt.) per orally, test group received Pyridostigmine (3.6mg/kg/day) per orally for 5 days. All rats were fasted overnight before the 5th day. On the 5th day 1 hour after the last dose of the respective drug, OGTT was performed. All the rats were given glucose (0.6gm/kg body weight) orally using oral feeding tube. Following this, the Capillary blood glucose (tail vein puncture) was assessed at 0, 60, and 150 minutes of time intervals using a glucometer (ACCUCHECK). Results: The Capillary Blood Glucose (CBG) levels of Pyridostigmine group was less when compared to control group at all-time intervals i. e., 60min, 90min and 150min. Conclusion: Pyridostigmine showed hypoglycemic activity compared to control when given for 5 days orally in euglycemic albino rats through OGTT.
| » DDDEO-9: Study on Therapeutic Drug Monitoring of Anti-epileptic Drugs among Epileptic Patients in Silchar Medical College and Hospital, Silchar | | |
Nath MK, Chakravarty P
Department of Pharmacology, Silchar Medical College and Hospital, Cachar, Assam, India
E-mail: [email protected]
Objective: Anti-Epileptic Drugs (AEDs) are the mainstays in treatment of epilepsy which are known to have a narrow therapeutic index and complex pharmacokinetic properties due to which wide fluctuations in their plasma concentration occurs, leading to toxic effects or loss of therapeutic efficacy. Methods: This study was carried out in the Medicine & Psychiatry outpatient & inpatient departments of Silchar Medical College & Hospital. A total of 69 patients of either sex between the age group of 18-75 years, diagnosed with epilepsy were recruited for the study after taking due consent. Patients on single AED only were recruited for the study and were analyzed for their plasma AED levels. Results: Out of the 69 patients, number of patients on Carbamazepine, Phenytoin and Valproic acid monotherapy were 9 (13.04%), 23(33.33%) and 37 (53.62%) respectively. Among patients receiving Carbamazepine, 7 (77.78%) and 2 (22.22%) patients had the drug levels within and above therapeutic range respectively. Among those receiving Phenytoin, 15 (65.22%), 4 (17.39%) and 4 (17.39%) had drug levels within, above and below therapeutic ranges respectively, and for patients receiving Valproic acid, 24 (64.86%), 3 (8.11%) & 10 (27.03%) were found to have serum levels within, above & below the recommended therapeutic ranges respectively. Conclusion: The study found that plasma drug levels of Carbamazepine and Phenytoin correlated well with their therapeutic or adverse effect profiles while it did not always correlate with serum levels of Valproic acid.
Keywords: Anti-epileptic drugs, epilepsy, seizures, therapeutic drug monitoring
| » DDDEO-10: Evaluation of Safety and Efficacy of Topical Nanoformulation of Paclitaxel in 4-Nitroquinoline-1-oxide Induced oral Cancer | | |
S Arulmozhi, Sarkar S, C Bothiraja, Mahadik KR
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
E-mail: [email protected]
Objective: To formulate a nanoformulation of Paclitaxel and evaluate its safety and efficacy in 4-NQO induced oral cancer in wistar rats. Methods: A nanoformulation of Paclitaxel was prepared and characterized. Adult male wistar rats were divided into 4 groups- normal control, oral cancer control, pure paclitaxel and paclitaxel formulation each containing 6 animals. Oral cancer was induced by site-specific topical application of 0.5% 4-NQO (0.20-0.24ml) thrice weekly for 8 weeks in all groups except normal control. After induction, oral cancer control group received blank formulation while pure paclitaxel and paclitaxel formulation groups received 1mg/kg drug twice weekly for 4 weeks by i.p. and topical application, respectively. The body weight, neutrophil count, hyperalgesia and histology of the tissue were determined. The RNA was extracted from tongue tissue and the expression of PCNA, EGFR, Caspase 3 were determined to evaluate efficacy and IL-1β and IL-6 were determined to evaluate the safety profile of formulation. Results: Treatment with paclitaxel formulation decreased PCNA and EGFR, increased Caspase-3 and increased total neutrophil count. There was significant decrease in hyperalgesia and no significant increase of IL-1 β and IL-6. There was marked decrease in epithelial dysplasia, reduced mitotic figures, inflammation and nuclear pleomorphism of cells. Conclusion: It is evident by the molecular studies that this paclitaxel formulation decreased proliferation of cells, increased apoptosis and decreased adverse effects associated with pure paclitaxel. The formulation was found to be effective in 4-NQO induced oral cancer in rats as compared to pure paclitaxel with decreased adverse effects.
| » DDDEO-11: Preclinical Evaluation of Cinnamic Acid Derivatives against Spatial Memory Deficit in Rats | | |
Mudgal J, Rijal S, Changdar N, Kumar A, Pai KSR
Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
E-mail: [email protected]
Objective: Ethyl-p-methoxycinnamic acid (EPMCA) and Ethyl-p-methoxycinnamate (EPMCM) are the phenylpropanoids. Literature reports the preliminary studies, where these compound possessed antioxidant and neuroprotective activities in scopolamine-induced acute dementia. The present study was carried out in order to determine effect of EPMCA and EPMCM against chronic spatial memory deficit in rats. Methods: Four months old male Wistar rats were procured from Central Animal Research Facility, Manipal University, Manipal. The experimental protocol was approved by Institutional Animal Ethical Committee, Manipal. Memory deficit in rats was induced by the chronic administration of aluminium chloride (AlCl3, 10 mg/kg, i.p.) from day-6 to day-64. Treatment with standard drugs (rivastigmine and memantine) and test molecules (EPMCA and EPMCM, 50 and 100 mg/kg p.o.) was continued from day-44 to day-64. Behavioural assessments for spatial memory and locomotor activity was performed using Morris Water Maze and open field test, respectively. Acetylcholinesterase (AChE) activity, catalase and thiobarbituric acid reactive substances were measured in the hippocampus and cortex region of rats' brain. Results: AlCl3 resulted in induction of chronic memory deficit in rats, which was significant on day 44 and 64 as compared with normal rats. Twenty days treatment with EPMCA and EPMCM at both doses improved the memory significantly as compared with disease control group. These results were supported by improved AChE activity and attenuation of oxidative stress in hippocampus and frontal cortex. Conclusion: Present study suggests the anti-dementia activity of EPMCA and EPMCM. Further studies are planned to elucidate their molecular mechanism.
| » DDDEO-12: Evaluation of Anti-bacterial Activity of Tagetes erecta in Comparison with Combination of Antibiotics | | |
Nenavath Vinay, Darling Chellathai David
Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu, India
E-mail: [email protected]
Objective: To evaluate the antibacterial activity of Tagetes erecta flowers in comparison with combination of antibiotics against gram-negative and gram-positive bacteria. Methods: We assessed antibacterial activity with agar disc diffusion method and minimum inhibitory concentration assay against S.aureus, P.aeruginosa  , E.coli, Klebsiella, Bacillus, Salmonella More Details, Aeromonas, Serratia, Vibrio. In agar disc diffusion method, Muller-Hinton Agar(MHA) medium is poured on petriplate, after medium was solidified, inoculums spread on the solid plates and moistened with bacterial suspension. 20μl sample added at various concentrations were placed in disc. The plates incubated at 370C for 24 hrs and antibacterial activity is determined by zone of inhibition. In MIC assay, 1 ml sterile LB broth distributed to every test tube and submitted for autoclaving at 1210C. After broth reaches room temperature add 1 ml sample in tube 1. This is done for 7 tubes and 100μl of bacterial cultures are added to 7 tubes and incubated at 370C, after incubation turbidity observed and MIC determined. Results: Tagetes erecta among gram-positive bacteria showed good antibacterial activity against Bacillus spp., with zone of inhibition 12- 16 mm diameter and MIC of 250 μg/ml in comparison with combination of antibiotics. In gram-negative good antibacterial activity against Proteus spp., with a zone of inhibition of 12-17 mm of diameter seen and MIC of 250 μg/ml in comparison with combination of antibiotics. Conclusion: Tagetes erecta has a good potential as an antibacterial agent against gram-positive and gram-negative organisms in comparison with combination of antibiotics.
Keywords: Agar disc diffusion, antibacterial, MIC, tagetes
| » DDDEO-13: Antibacterial Activity of Rasamanikya and Rasasindoora on Nitrofurentoin Resistance E. coli Isolated from Urinary Tract Infection | | |
Shashirekha KS, Raghavendra MP
Department of Microbiology, Maharani's Science College for Women (Affiliated to University of Mysore), Mysore, Karnataka, Research and Development Center, Bharthiar University, Coimbatore, Tamil Nadu, India
E-mail: [email protected], [email protected]
Objective: To Screen Nitrofurentoin resistant E.coli by Kirby Bauer method. To assess the efficacy of herbomineral drugs on Nitrofurentoin resistant E.coli. Methods: Nitrofurentoin resistance E.coli were isolated by Kirby Bauer disc diffusion method, these E.coli were subjected to antibacterial assay against Rasamanikya and Rasasindoora. Different concentrations of Rasa sindhoora and Rasa manikya were treated with Nitrofurentoin resistant E.coli by cup diffusion method. Results were tabulated. Results: Rasa sindhoora and Rasa manikya different concentrations were prepared by dissolving in distilled water and treated with Nitrofurentoin resistant E.coli by well diffusion method. 18mm and 20mm zone of inhibition were reported in 0.25μg concentration respectively in both the Rasa manikya and Rasa sindoora. By this study Rasa sindoora and Rasa manikya were showing significant antibacterial activity against Nitrofurentoin E.coli and this can be use against multidrug resistant bacteria causing various infectious disorders. Conclusion: The present study conclude that the emergence of Nitrofurentoin resistant E. coli isolated from UTI are increasing with the increased usage of Nitrofurentoin antibiotic, limited use of Nitrofurentoin prescription may decreases the increasing Nitrofurentoin resistance in UTI caused by E. coli. Use of alternative medicine like Rasamanikya and Rasasindoora are helpful in eradication the drug resistance in E. coli.
Keywords: Herbomineral, rasa manikya, rasa sindhoora
| » DDDEO-14: Pharmacological Evaluation of Mefenamic Acid Derivative in the Treatment of Hepatocellular Carcinoma | | |
Patel SS, Tripathi R, Savjani JK
Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
E-mail: [email protected]
Objective: Numerous studies suggest that NSAIDs reduce cancer cell proliferation, progression, angiogenesis, apoptosis and invasiveness. The current study focuses on evaluation of Mefenamic acid derivatives for treatment of hepatocellular carcinoma. Methods: Synthetic derivatives of Mefenamic acid were subjected to molecular docking for prediction of pharmacological activity using Pass online software, followed by cytotoxicity study using MTT assay. Disease was induced with N-Nitrosodiethylamine followed by 2-acetlyaminofluorene orally for 2 weeks. After 12 weeks of induction, treatment was given for the period of one week. At the end liver weight, number of nodules, determination of biochemical parameters, immunohistochemistry, histopathology and gene expression study was carried out. Results: Based on molecular docking score for PDGFRα and IC50 values in HepG2 celline study JS-PFA was selected for in-vivo study. In pharmacological evaluation, we have found statistically significant reduction in number of nodules and liver weight with treatment with JS-PFA. Protective role of JS-PFA has been observed in tumor marker specific markers like AFP, CEA, and these levels were found to be decreased in JS-PFA treated group. The JS-PFA also has shown significantly significant reduction in PDGF-alpha levels as well as liver markers like (ALT, ALP, AST, LDH) and total bilirubin levels. On histopathological analysis protective effect of JS-PFA was clearly visible. Conclusion: The results of expression immunohistochemical analysis of P53 and down regulation of VEGF and MMP-9 genes suggest that beneficial effect of JS-PFA may be due to apoptotic, antiangiogenic, antimetastatic and antimitotic effect.
| » DDDEO-15: To Analyze the Catastrophe Incurred during Drug Development in Health Care | | |
Hajra Irshad, Gaddamedhi Arun Jyothi, Chakradhar T, Orooj Fathima, Resu Neha Reddy, RaviNaik Nunavath
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: To analyze the catastrophe incurred during drug development in health care. Methods: It is a retrospective observational study, where data has been collected from various official drug regulatory sites. The study is done to analyze the clinical trial failures in phase 3, rationale behind it, losses incurred and measures to be taken to overcome it. Results: In our analysis, we have noticed, numerous drugs that failed to clear the phase 3 clinical trials. Here, we are quoting few examples, from an ocean of failures, like, Serelaxin (RLX 030), a drug for acute heart failure (AHD) failed in global, 3.5 years, 6600-patients phase 3 study, due to inefficiency in the choice of the endpoints and short period of study. Huge losses were incurred, financially, with a decline in net income of the company. Another failure was RSV F (F-protein nanoparticle vaccine) that failed to meet its endpoints in phase 3 Resolve trial, with 11,856 adults aged 60 & older, root cause for failure is under investigation. Major losses were incurred both in workforce and net income, in addition to other losses. Conclusion: Trials with longer period of study, definite eligibility & non-eligibility criteria for the participants in the trial, comparative study with a standard drug rather a placebo, elaborative pre-clinical trials and better insight of the study being conducted will help reduce the losses (deaths, loss of workforce, financial loss, failure of the drug in clinical trial) incurring during the study.
| » DDDEO-16: Efficacy of Herbo-mineral Preparations on Multidrug resistance Staphylococci sps (MDRS) Isolates from PUS | | |
Nandesh Mohan P, Hashirekha KS
Roganidana and Vikruthi Vijnana, Shree Dharmasthala Manjunatheshwara Ayurveda College and Hospital, Hassan, Karnataka, India
E-mail: [email protected]
Objectives: To check the efficacy of Herbo-mineral preparations on multidrug resistance Staphylococci (MDRS) isolated from Pus. Methodology: Study includes the Pus isolated Staphylococci spp which showed resistance against the maximum number of antibiotics were selected for antibacterial assay against herbo-mineral drugs. Different concentrations of gum acacia suspension of Rasa sindhoora, Vyadhihara rasayana, Rasa manikya and Gandhaka rasayana were treated with multidrug resistant Staphylococci spp by cup diffusion method. Results: Different concentrations of herbomineral drug were treated with Vancomycin, Clindamycin Penicillin and Methicillin Erythromycin resistant Staphylococcus spp. It was observed that the above mentioned Herbo-mineral drugs were showing significant susceptibility against MDRS, Vyadhihara rasayana used in this study were showing 18 mm of zone of inhibition in 0.25 μl concentration against Staphylococci sps. Conclusion: Herbo-mineral formulations of Ayurveda, constituting bhasma as an ingredient, are the superior forms of administration of Nano medicine. In the medieval period, it was widely accepted because of its minimum dose schedule and higher efficacy, As there is flaring up of multidrug resistant organisms in present day, there is a need for finding safe, cost effective drug, in which Rasa sindhoora, Vyadhihara rasayana, Rasa manikya Gandhaka rasayana may be an ideal replacement in certain multi drug resistance bacterial infections.
Keywords: Antibiotic rasa manikya gandhakarasayana, herbomineral
| » Dermal Pharmacology Oral | | |
| » DPO-1: Dispensing Errors in Relation to Dermatological Prescribing: A Short Term Observational Study | | |
Bala M, Chatterjee S1, Hazra A1, Chatterjee G2, Sen S2
Departments of 1Pharmacology and 2Dermatology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
E-mail: [email protected]
Objectives: To identify the frequency of dispensing errors in relation to dermatological prescribing in a tertiary care hospital set-up and to generate a profile of the nature of such errors. Methods: Adult subjects or minors accompanied by guardians attending dermatology OPD were asked to return with their dispensed medicine if this was being procured from retail pharmacies within 1 km radius. The medication label was cross-checked against the actual prescription. If any discrepancy was noted, subjects were queried about events at the retail pharmacy. Results: OPD was attended once per week over 6 months. The first 20 prescriptions generated on the study day for subjects who could return to show the medication were studied. Total 50 dispensing errors were recorded from scrutiny of 436 prescriptions, giving a dispensing error rate of 11.47% (95% confidence interval 8.81 – 14.8%). Total 151 drugs were prescribed of which 85 (56.29%) were topical. In general, each prescription had 2-3 drugs. For the 50 dispensing errors, no more than 1 per erroneous serving of prescription was noted. Of the total errors, 32 (64.0%) concerned topical formulations and 22 (44.0%) pertained to formulations with multiple active ingredients. In 50% cases, the discrepancy was the result of the retail pharmacy deliberately substituting for preparations not available. Conclusions: Dispensing errors occur with appreciable frequency in dermatological prescribing and may be the result of inappropriate substitution. Cross-checking medication obtained at retail pharmacies, before their actual use, is desirable if feasible.
Keywords: Dermatology, dispensing error, topical medication
| » DPO-2: A Comparative Study of Efficacy and Safety of Topical 4% Hydroquinone and 0.75% Kojic Acid Cream in the Treatment of Facial Melasma | | |
Pradeep Y, Sharon Sonia S
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Objective: To evaluate the efficacy and safety of topical 4% hydroquinone and topical 0.75% kojic acid in the treatment of facial melisma. Methods: We have conducted this study in the Out-patient Department of DVL, GGH, Kurnool during Aug 2015 –16. 60 patients with facial melasma were assessed. Patients were grouped into groups A and B by randomization. Patients in Group A and Group B were treated with 4% Hydroquinone and 0.75% Kojic acid respectively. At weeks 4, 8 and 12, response to the treatment was evaluated. Efficacy was assessed at every visit using the MASI score. Results: Mean change in MASI score from baseline at week 4 [-3.6 (2.8) vs. -0.8 (1.3), p=<0.001], at week 8 [-6.7(3.6) vs. -2.1 (1.9), p=<0.001] and at week 12 [-10.1 (4.1) vs. -3.0 (2.1), p=<0.001] was highly significant statistically in Group A than in Group B. Erythema [6.7%] and burning sensation[10 %] were observed in Group A and Group B patients respectively. Conclusion: From the results of the study, we could say that 4% Hydroquinone is more effective when compared to 0.75% Kojic acid in the treatment of facial melasma. Both these hypopigmenting agents are safe as no harmful side-effects were observed.
| » DPO-3: Case Study of Cefixime Induced Toxic Epidermonecrolysis | | |
Alladi Satyendra Kumar, Srinivas Velupula1 Raju Devde
KMC, 1KMC/MGM Hospital, Waranga, Telangana, India
E-mail: [email protected]
Objectives: Importance of Pharmacovigilance awareness among common people and healthcare professionals to report serious adverse drug reactions. Introduction: Toxic Epidermal Necrolysis (TEN) is potentially life threatening condition with widespread epidermal detachment and mucosal erosions. TEN represents skin detachment of more than 30% of the body surface area. The exact pathogenesis of TEN still remains unknown. Role of humoral immunity which was previously thought has fallen into disrepute in favor of cytotoxic T-lymphocyte mediated immune reaction at destruction of keratinocyte expressing foreign (drug related) antigens as the primary cause for development of TEN. The present case study also represents one of the dreaded reactions with cefixime, Case Details: A 45 year old male patient who was prescribed with Cefixime (200 mg) two tablets per day for fever, After one day he developed erythematous macules over back and then gradually spread to involve front of abdomen, upper and lower limbs in one day. Then he developed blisters over the erythematous macules on next day and rash extended rapidly in 4 days to involve whole body. History of pain, burning sensation and marked tenderness of skin was present. The epidermis separated in sheet of size 4x5 cm in the lower back. Conclusion: Patient was treated and completely recovered in 3 weeks. We analyzed the ADR using WHO Causality assessment scale and found it to be probable reaction, so the health care providers should be aware of dreaded ADR with antibiotics like Cefixime.
Keywords: Cefixime, toxic epidermonecrolysis
| » DPO-4: A Comparative Study on Efficacy of Topical Clindamycin with Dapsone Gel in the Treatment of Acne Vulgaris | | |
Verma R1,2, Yadav P1,2
1Department of Pharmacology, Government Medical College, 2Veer Narmad South Gujarat University, Surat, Gujarat, India
E-mail: [email protected]
Objectives: This study was undertaken to compare the efficacy of topical clindamycin gel and topical dapsone gel in mild to moderate acne vulgaris. Materials and Methods: 40 patients of age >12 with grade I and grade II acne of the face were enrolled. All the patients applied clindamycin 1% on one side (right) and 5% dapsone gel on the other side (left) simultaneously for 12 weeks. Total number of lesions (inflammatory and non inflammatory) were counted, compared and adverse effects were assessed at 0, 4, 8 and 12 weeks. P value of <0.05 was considered significant. Results: Out of 40 patients, females constituted 60% and males 40%. There was a significant reduction in the mean lesion count of comedones, papules and pustules (p<0.05) on both the sides from baseline level at 4, 8 and 12 weeks. With dapsone gel, 65% patients showed good improvement whereas with clindamycin 72% of the patients showed fair improvement at 12 weeks. Overall improvement was 50.0% with dapsone gel as compared to 55.5% with clindamycin. At the end of 8th and 12th week of treatment the results of the dapsone treated side were significant and superior for the reduction of inflammatory lesions compared to the results of clindamycin. Both treatments were well tolerated. Conclusion: Our study suggests that dapsone 5% gel and clindamycin 1% gel have almost equal efficacy when compared after 12 weeks of therapy. But dapsone 5% gel therapy is slightly better than clindamycin 1% gel therapy for inflammatory lesions.
| » DPO-5: A Study on Antibiotics Induced Cutaneous Adverse Drug Reactions at a Tertiary Care Hospital Mysore | | |
Konnur SS1, MS Kishore, BL Najund Swamy
Department of Pharmacology, Mysore Medical College and Research Institute, Mysore, Karnataka, India
E-mail: [email protected]
Objectives: To obtain information about antibiotics induced cutaneous adverse reactions and to establish the causal relationship. Materials and Methods: Observational cross sectional study , a total of 76 patients were presented as adverse cutaneous reaction in dermatology outpatient department of K R HOSPITAL MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE MYSORE, 30 patients developed cutaneous adverse reactions due to antibiotics .The details of cutaneous adverse drug reactions were recorded in ADR form of Central Drugs Standard Control Organisation (CDSCO). Causality was assessed using World Health Organization- Uppsala monitoring centre (WHO-UMC) criteria. Results: 76 patients with antibiotics induced CADRs were included in the study during the 6 months study period. Results were presented in the form of number and percentage. Most common age group with antibiotics induced CADRs was 20-30years; with( 66.66%) of females ,(33.34%) male and the most common suspected antibiotic group causing CADRs was Fluoroquinolones, and Cephalosporins (33.33%), and most common lesion is maculopapular rashes (40% ),urticaria (36.66%) Steven johnsons syndrome (13.35%), angioedema (16.66%). According to WHO –UMC 67.30% of CADRs were probably caused by antibiotics and 32.7 were possible. Conclusions: Wide variety of drugs causes CADRs. Awareness among clinicians is required for active reporting of CADRs. Patients need to be educated for the cautious use of drugs causing ADRs to prevent the same.
| » DPO-6: Evaluation of Efficacy and Safety of High Dose Second Generation Non-sedating Antihistamines Levocetrizine and Fexofenadine in Chronic Urticaria- A Prospective, Parallel, Randomized, Single Blind, Comparative Study | | |
Bisoi D1, Donepudi A1*, Mekala P1, Sreepathi Panditharadyula V 2
Departments of Clinical Pharmacology and Therapeutics and 1Dermatology, NIMS, Hyderabad, Telangana, India
E-mail: [email protected]
Objectives: The first line drugs, recommended for chronic urticaria are nonsedating antihistamines. There are few studies with up dosing of different antihistamines. All are single armed and non-randomized studies. The present study was to evaluate the efficacy and safety of high doses of second generation antihistamines levocetrizine and fexofenadine in chronic urticaria. Methods: In this prospective, parallel, randomized, single blind, comparative study, patients with moderate to severe pruritus and urticaria were included. Twenty four patients were randomized either to Fexofenadine 180 mg or Levocetrizine 5 mg groups. Patients were monitored weekly up to 4weeks.The dose of Fexofenadine was doubled to 360 mg and Levocetrizine to 10 mg at the end of 1 week in non-responders. The dose of Fexofenadine was increased to 540 mg and Levocetrizine to 20 mg at the end of 2 weeks in non-responders. These doses were continued till the end of study (4 weeks). Patients who completed 2 week treatment with highest dose were included in the analysis. All patients were evaluated for symptoms (degree of pruritus, number and size of wheals and number of urticarial episodes per week) visual analog scale for sedation and critical flicker fusion threshold (CFFT) for coordination before and after study. Results: The change in mean total symptoms score was highly significant in Fexofenadine group than Levocetrizine group. There was a highly significant decrease in CFFT in Fexofenadine group. Conclusions: Fexofenadine is superior to Levocetrizine in reducing mean symptoms score and sedation and improving coordination in patients with chronic urticaria.
Keywords: CFFT, chronic urticaria, nonsedating antihistamines, sedation
| » Ethno Pharmacology Oral | | |
| » ETHO-1: A Beneficiary Effect of Methanol Extract of Crassocephalum crepidiodes Induced Wound Healing – Histological Picture of Granulation Tissue in Dead Space Method in Albino Rats | | |
Banerjee Priyotosh1,2
1Department of Pharmacology, Regional Institute of Medical Sciences, 2Manipur University, Imphal, Manipur, India
Objective: To display the histological picture of granulation tissue in dead space wound model in albino rats. Methods: Three groups of six albino rats of either sex were obtained and were kept in separate cages for 7 days. They were fed with standard pellet of diet with free access of water. Three groups were made: Group I – Control: 2% gum acacia at 1ml/100gm body weight p.o Group II – Test 1: Methanol extract suspension of Crassocephulum crepidiodes at 100 mg/kg body weight p.o Group III – Test 2: Methanol extract suspension of Crassocephulum crepidiodes at 200 mg/kg body weight p.o On day 8 after overnight fasting all groups were treated and a wound was created on their left axillary region under ether anaesthesia. A cylindrical glass pith of 2.5×0.5 cm was inserted and stitched with 4-0 silk. The treatment was continued for 10 days and then wound was opened and glass piths taken out. The surrounding tissue was separated and preserved in 10% formalin and examined for histological feature. Results: Plenty of inflammatory exudates with predominance of polymorphs with newly formed blood vessels could be identified in the group I tissues. Tissues from Group II showed mixed inflammatory cells with polymorphs, lymphocytes and macrophages with scanty fibroblasts. Group III showed granulation tissues mixed with inflammatory cells, proliferating fibroblasts and lymphocytes. Plump fibroblasts, neovascularisation and laying down of collagen fibres with reduced inflammatory cells could be identified. Conclusion: The test compound shows evidence of enhancing granulation tissue formation helping in wound healing.
| » ETHO-2: Preclinical Studies of Lagerstromeia speciosa Stem Extract in High Fat-fructose Fed Prediabetic Rats | | |
Waghmare RS, Tatke PA
C. U. Shah College of Pharmacy, Sir Vithaldas Vidyavihar, SNDT Women's University, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: Diabetes, if detected and treated at prediabetic stage can be reversed. Traditional medicine system of India, recommends the use of plant based medicines for treating assorted disease conditions. Leaf of Lagerstroemia speciosa is studied extensively for diabetes treatment, however stem is not studied yet. The present study aims at preclinical evaluation of extract of stem of Lagerstroemia speciosa in prediabetes. Methods: High fat diet (HFD) comprising of approximately 65-70% fat and fructose was fed to rats for 15 weeks to induce Prediabetes. Extract was given per orally at dose level of 200 mg/kg/day for 4 weeks along with continuation with feeding HFD. Pioglitazone (3 mg/kg/day) was given as standard control. Weight and fasting blood glucose levels estimated weekly. Biochemical parameters were estimated on day 0, every month and at the end of intervention. Results: Prediabetic rats treated with extract, showed significant decrease in blood glucose levels and biochemical parameters (serum lipid level, blood urea nitrogen, serum Creatinine and liver markers). Reduction in lipid levels, attenuation of blood urea nitrogen, serum Creatinine and liver markers indicated that stem extract also improved renal and liver dysfunction associated with prediabetic hyperglycemia. Conclusion: Stem extract of Lagerstroemia speciosa can be considered as promising candidate for treatment of prediabetic condition.
| » ETHO-3: Characterisation of Saraka asoca flower (Roxb.)Wilde with its Antianxiety and Antidepressant Activities in Animal Models | | |
Shashikumara, Prathima C, Srinivasa K
Department of Pharmacology, Chamarajanagar Institute of Medical Sciences, Chamarajanagar, Department of Pharmacology, JSS Medical College, Mysuru, Karnataka, India
E-mail: [email protected]
Ethanopharmacological Relevance: Saraka asoca (Roxb.) Wilde (Ashoka) has been widely used in India as uterine tonic, Grahi, Varnya, Apache hara, Hrudya, Gulmahara, Shulahara in Ayurvedic medicine. Aim of the Study: To focus on the analysis of chemical constituents of the Saraka asoca flower (Roxb.) Wilde and to evaluate the effect of ethanolic extract of Saraka asoca flower (ESAF) on acute restraint stress (ARS)-induced depression and anxiety in mice models. Materials and Methods: Methanol fractions of EASF was analytically characterized by Liquid Chromatography-Mass Spectrometry (LC-MS) and High performance liquid chromatography (HPLC). Behavioural animal models, namely, elevated plus maze (EPM), light-dark box (LDB), forced swim test (FST) and tail suspension test (TST) were employed to evaluate the effect of ESAF on anxiety and depression among albino mice. Statistical Analysis: The results were expressed as mean ± S.E.M. Statistical analysis was done by One- way ANOVA test followed by Post-hoc Dunett's multiple comparison test. p<0.05 was considered statistically significant. Results: Characterisation of methanol fractions of ESAF showed the presence of bioflavonoids namely, Myricetin, quercetin, and Rhamnazin. In animal models, ESAF showed significant anti-anxiety activity (p<0.05) as depicted by an increase in the time spent in open arms of EPM, and in the light box in LDB test. ESAF also significantly reversed the acute restraint stress (ARS) induced depressive like behaviour in mice studied by the behavioural despair models, viz. FST and TST. Conclusions: Ethanolic extract of Saraka asoca flower showed presence of various bioflavonoids like, Myricetin, quercetin, and Rhamnazin. Myricetin is a proven potent anti-oxidant and inducer of the enzyme GST (Glutathione-S transferase). ESAF also exhibited significant anti-anxiety and antidepressant activities in the mice screening models which may be attributed to the presence of various bioactive constituents.
Keywords: Acute restraint stress, immobility, saraka asoca flower
| » ETHO-4: Effect of Glycyrrhiza glabra Extracts in Tibial and Sural Transection Induced Neuropathic Pain in Rats | | |
Joshi TA, Tatke PA
C. U. Shah College of Pharmacy, SNDT Women's University, Sir Vithaldas Vidyavihar, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Neuropathic pain (NP) has been described as worst of tortures which a nerve wound may experience as a result of nerve damage, complication of diabetes, HIV infection and cancer. There are no defined guidelines for treatment and available treatments have various undesirable side effects. Hence, patients experiencing pain try numerous therapies including Ayurveda. Glycyrrhiza glabra has not been studied scientifically with respect to NP. Hence there is a dire need to develop treatment strategies for NP which will be safe, effective & can be taken for prolonged time. Methods: Plant material was extracted using various solvents. The prepared extracts were tested for antioxidant activity by various methods. NP was induced by Tibial and Sural transection (TST) which is extensively used by researchers for inducing NP. After inducing this model, it leads to induction of chemical and heat evoked hyperalgesia cold and mechanical allodynia and some symptoms of spontaneous pain. At the end of the study biochemical parameters; superoxide generation, malondialdehyde (MDA), protein and TNF-α were evaluated from tissue homogenate. Results: TST gave rise to symptoms of neuropathic pain such as, decrease in nociceptive threshold for heat hyperalgesia. Rats treated with Glycyrrhiza glabra extracts (GGE) showed improvement all the pain related symptoms. Treated rats also showed improvement in tibial functional index. Rats treated with GGE showed improvement in biochemical parameters such as production of superoxide ions and MDA. Conclusion: Glycyrizza glabra extracts can be a potential candidate for treatment of neuropathic pain.
| » ETHO-5: To Study Availability of Over the Counter Topical Ocular Drugs in Indian Market and Review Pharmacological Basis of Therapeutic Constituents | | |
Virani S, Rewri P1
Departments of Pharmacology and 1Ophthalmology, Maharaja Agrasen Medical College, Hisar, Haryana, India
E-mail: [email protected]
Objective: To collect over the counter (OTC) ocular drugs from market and to review literature about pharmacological basis of constituent components, Methods: In this study we procured various available OTC topical eye drops from retail market. We studied constituent components of each eye drop. Literature search was done for each individual component for their pharmacological properties and therapeutic uses. We looked for level of evidence for each available literature. Claimed clinical indications were weighted for level of evidence as per recommendations of NHMRC. Results: A total of 13 OTC eye drops were available in retail Indian market, of which 6 are marked by pharmaceutical companies marketing other allopathic drugs. Overall, we studied 37 therapeutic constituents available in different eye drops. Most constituents found to have anti-inflammatory properties but none of them had good level of evidence. Clinical indications for OTC drugs ranged for various eye diseases including cataract, glaucoma, diabetic retinopathy and refractive errors. Conclusion: There is need to conduct randomized clinical trails to know therapeutic benefits of constituents of OTC drugs.
| » ETHO-6: Evaluation of Antiarthritic and Immunomodulatory Effect of Boswellia serrata Extract in Freund's Adjuvant Induced Arthritic Rats | | |
Kumar R, Saksena AK, Pal R, Singh S, Kumar R, Jaiswal R1
Departments of Pharmacology and 1Pathology, King George's Medical University, Lucknow, Uttar Pradesh, India
E-mail: [email protected]
Aim and Objectives: To compare the anti-arthritic effect of Boswellia serrata Extract (BSE) with standard drug Indomethacin in animal model of adjuvant-induced Rheumatoid Arthritis (RA). Materials and MethodS: 36 rats were divided in 6 groups. Baseline measurement for parameters like body weight, ankle diameter, paw thickness and paw volume was done on day 0. RA was developed within 5 days after injection of Complete Freund's Adjuvant (CFA), 0.1ml, intradermally in left hind paw barring control group. All rats were studied for an acute inflammatory lesion of arthritis. The treatment with Indomethacin (3mg/kg in distilled water) in one group and BSE (45, 90 & 180mg/kg in distilled water) in 3 groups was orally administered from day 5 to 15. Same parameters along with arthritic index and TNF-α was measured on day 5 and 15. On day 15 all rats were sacrificed and inflamed limbs were excised above the ankle joints and examined for a pathological finding of rheumatic arthritis. Results and Conclusion: Only BSE (180mg/kg) showed significant improvement in body weight and decrease in ankle diameter, paw thickness & paw volume, and arthritic index. This was comparable with Indomethacin. However, lower doses of BSE did not show significant improvement. TNF-α did not show any significant decrease. Only BSE (180mg/kg) as effective as compared to lower doses but less than Indomethacin 3mg/kg. The higher dose of BSE might have a potential usefulness as an adjunct to conventional therapy for management of rheumatoid arthritis.
| » ETHO-7: Evaluation of the Antihyperglycemic Effects of Aqueous extracts of Psidium guajava Leaves in Streptozotocin-induced Hyperglycemia in Albino Rats | | |
Kairi VS, Nath MK, Purkayastha A
Department of Pharmacology, Silchar Medical College and Hospital, Cachar, Assam, India
E-mail: [email protected]
Objective: This study was undertaken to evaluate the antihyperglycemic potential of Psidium guajava Linn. (Myrtaceae) leaves in streptozotocin-induced hyperglycemia in albino rats. Methods: The aqueous extract of P. guajava leaves was prepared. For the experiment 6-9 week old albino Wistar rats weighing from 160 g to 200 g were selected. Oral glucose tolerance test model and streptozotocin induced diabetic test model were performed to evaluate the antihyperglycemic activity. Blood glucose was measured with the help of glucose oxidase method. Results: Administration of Psidium guajava leaf extract significantly (P<0.05) decreased blood glucose levels in oral glucose tolerance test model as well as in streptozotocin induced diabetic model in albino Wistar rats. Conclusion: These results show significant antihyperglycemic activity of aqueous extract of Psidium guajava leaves in albino Wistar rats.
Keywords: Diabetes mellitus, glucose tolerance test, hyperglycemia, Psidium guajava, streptozotocin,
| » ETHO-8: Assessment of the Anti-Obesity Potential of Fractions of Distillated Cow Urine Using Non-Invasive Approach | | |
Karri S, Sharma S, Hatware K
School of Pharmacy and Technology Management, NMIMS, Shirpur, Maharashtra, India
E-mail: [email protected]
Objective: Owing to multifactorial pathological condition management of obesity is a serious problem. Thus finding effective and safe remedy is the huge area of interest for many scientist and healthcare professionals. Many naturally occurring components have shown good therapeutic effects for the treatment of obesity and cow urine is one of them. There is a traditional claim that fresh cow urine as well as its distillate have anti-obesity activity. Thus the present study aimed to assess bioactive fraction of distillated cow urine having anti-obesity potential. Methodology: Distillated cow urine was extracted by liquid-liquid extraction using different solvents. Distillated cow urine and all the fractions were assessed for the antiobesity activity in high fat diet induced obese rats for 45 days by analysing non-invasive parameters such as abdominal circumference, body weight, body mass index, obesity index, locomotion, motor activity, food consumption and quantity of faeces. Results: The results of the study shown that distillated cow urine, methanolic fraction and Butanol fraction have reduced abdominal circumference, body weight, body mass index, obesity index. In addition to that the supporting parameters like locomotion, motor activity and faces excretion have been increased in distillated cow urine, methanolic fraction and n-butanol fraction treated groups as compared to control group but consumption of food was unaffected in all the groups. Conclusion: The distillated cow urine and its methanolic as well as butanolic fraction have shown significant anti-obesity potential, as per the observations in this study it has been found that body weight reduced without affecting the food consumption, probably due to reduction in dietary fat absorption by reducing the pancreatic lipase activity and enhancing its excretion in faces. Further research is required to explore the exact mechanism of action for its anti-obesity potential.
Keywords: Anti-obesity, cow urine, fraction of cow urine, lipase inhibition
| » ETHO-9: Active Ingredients of Neem Plant Produced Promising Therapeutic Effects in Pulmonary Fibrosis | | |
Chandraiah Godugu, Prashanth Goud, Gauthami Pulivendala, Swarna Bale
Department of Regulatory Toxicology, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: Our study is aimed at evaluating efficacy of Nimbolide, an active constituent of Azadiracta indica (Neem), in TGF-β induced in vitro and bleomycin induced in vivo pulmonary fibrosis (PF), slightly emphasising its effect on autophagy. Methods: TGF-β1 was used to reciprocate fibrotic changes in vitro in HFL 1 and A549 cells. Effect of Nimbolide in the aforementioned fibrosis induced cells was evaluated by studying protein expression through western blotting. PF in vivo was developed in Swiss mice by administering bleomycin oropharyngeally. Mice were treated with Nimbolide at doses of 100μg/kg & 300μg/kg, intra-peritoneally for 21 days. Oxidative stress markers, inflammatory cytokines and fibrotic parameters were evaluated in lung tissues homogenates. To demonstrate effect of Nimbolide at molecular level immunohistochemistry (IHC) and confocal protein expression studies were performed. Results: The results of our study demonstrated the anti-fibrotic potential of Nimbolide. In vitro immunoblotting showed significant reduction in mesenchymal, fibrotic markers and a substantial upregulation of epithelial markers. Consistent results were obtained from western blots of whole lung homogenates. Further supporting this, IHC of α-SMA and TGF-β showed reduced distribution of positive signals in Nimbolide treated tissues. Nimbolide eloquently regulated autophagy signalling by dampening LC3 expression and increasing beclin expression as evidenced by immunoblotting and confocal microscopy. Additionally, expression of p62 was found to be decreased by Nimbolide at both doses. Conclusion: Our study sheds light on the importance of often neglected natural products in treatment of PF. Study results demonstrates Nimbolide as a potent anti-fibrotic agent and its ability to regulate fibrosis associated autophagy.
| » ETHO-10: In vitro Antioxidant and Antiinflammatory Properties of Traditional Herbal Plants (Cuscuta reflexa and Cocculus hirsutus) | | |
Anita Singh, Vandana Singh
National Institute of Nutrition, Hyderabad, Telangana, India
E-mail: [email protected]
Introduction: The Oxidative profile of many plants is being regularly documented. There are few plants which have Nutritional importance and medicinal use which are rarely been exploited for determining the potential therapeutic activities. The use of Cuscuta reflexa and Cocculus hirsutus for medicinal and dietary purpose respectively. Objective: The aim of the study is to primarily evaluate the antiinflammatory and antioxidant effects of two Cuscuta reflexa and Cocculus hirsutus using in-vitro system. Methodology: The extracts prepared by traditional (Kwath) and modern method. The antioxidant activity was evaluated by DPPH assay. The capacity to quench ROS was evaluated by DCFDA in LPS stimulated Raw 264.7 macrophages cell line. Results: The free radical scavenging activity IC50 of Cr (33.5 ug/ml), Ch (70ug/ml) and Vitamin C(2.5ug/ml). Inhibition of reactive oxygen in LPS stimulated Raw 264.7 macrophages was reported at concentration of 62.5 ,31.25,15.6 & 7.8 ug/ml against LPS stimulated condition in water extracts of plants. Similar results have been reported with alcoholic and hydro-alcoholic extracts of plants. Conclusion: The potential AO of plants screened have demonstrated that kwatha has similar activity as compared to alcohol & hydro-alcoholic. This validates traditional therapeutic claims.
| » Gastrointestinal Oral | | |
| » GIO-1: Hepatoprotective Effect of Methanolic Extracts of Enhydra Fluctuans Lour. On Paracetamol- induced Liver Toxicity in Rats | | |
Deka J, Gohain K
Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam, India
E-mail: [email protected]
Objective: This study was carried out to evaluate the hepatoprotective effect of methanolic extracts of Enhydra fluctuans lour on paracetamol- induced liver toxicity in rats. Methods: Paracetamol was used at a dose of 400mg/kg orally for 7days to induce hepatocellular injuries in wistar albino rat. Methanolic extract of Enhydra flutuans lour was administered orally at a dose of 400 mg/kg body weight daily for 7 days. To asses hepatoprotective effect of the extracts various biochemical parameters i.e. serum total bilirubin, total protein, aspartate transaminase, alanine transaminase and alkaline phosphatase were studied. Results: Result of the study showed that there was significant increase in the level of total bilirubin, aspartate transaminase, alanine transaminase and alkaline phosphatase along with decreased total protein level in the paracetamol treated group indicating liver injury caused by paracetamol. In the group of animals treated with methanolic extract of Enhydra fluctuans lour, significant decrease in the levels of serum markers and increase in the total protein was seen indicating the protective effect of the extract against paracetamol induced liver damage. Silymarin (200 mg/kg, p.o.) was used as a reference drug. Conclusion: The result of present study showed that methanolic extract of Enhydra fluctuans lour has a protective effect against paracetamol-induced acute hepatotoxicity in rats.
| » GIO-2: Protective effect of leaf extract of Ficus glomerata in acetaminophen induced liver toxicity in zebrafish larvae | | |
Shaikh AS1,2, Mohammed I3, Khan M4
1School of Pharmacy, AIKTC, 4Oriental College of Pharmacy, Navi Mumbai, 2JNTUH, Hyderabad, 3PNR College of Pharmacy, Muchintal, Telangana, India
E-mail: [email protected]
Objective: Acetaminophen is the most common drug used as analgesic and antipyretic agent. At therapeutic dose it has no side effect however at higher dosage it induces liver damage. The present investigation aimed to study protective effect of leaf extract of Ficus glomerata against acetaminophen induced liver injury in zebrafish larvae. Methods: Three specific phenotypic endpoints (liver degeneration, changes in liver size and yolk sac retention) were used for assessing hepatotoxicity induced by acetaminophen in zebrafish larvae. Image J software was used to quantify extend of liver damage and to calculate liver and yolk sac area. Data was analyze by one way ANOVA with post-hoc Tukey HSD Test. Also antioxidant activity and quantitative estimation of total flavonoids and polyphenols of leaf extract was estimated. Results: Acetaminophen showed significant (p<0.01) liver degeneration, reduced in liver size and increase in yolk sac area in adult zebrafish as compared to the normal control group which indicate extend of hepatotoxicity produced by acetaminophen. Leaf extract of Ficus glomerata significantly (P<0.01) restore acetaminophen induced phenotypic changes in zebrafish larvae. Quantitative estimation of plant extract revealed presence of 134.62 ± 0.17 mg/g QE of flavonoid and 144.04 ± 3.05 mg /g GAE of polyphenols. In addition extract showed very strong antioxidant activity in DPPH, hydrogen peroxide radical scavenging and reducing power assay. Conclusion: The present study revealed hepatoprotective and antioxidant activity of Ficus glomerata leaf extract which might be due to its high content of total flavonoids and polyphenols.
| » GIO-3: Gastro protective effect Ocimum Sanctum linn (Tulsi) against Indomethacin-induced Gastric Damage in Albino Rats | | |
Mrutyunjay M
Department of Pharmacology, GIMS, Gadag, Karnataka, India
E-mail: [email protected]
Background: Peptic ulcer disease (PUD) encompassing gastric and duodenal ulcer is the most prevalent gastrointestinal disorder. Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin are used in the treatment of inflammation, fever and pain. However, NSAIDs cause gastric damage as a major adverse reaction. In this study, the gastro protective effect of O. sanctum was studied and compared with omeprazole in indomethacin- induced ulceration in albino rats. Objectives: To evaluate the protective effect of O. Sanctum against gastric damage induced by Indomethacin in albino rats. Materials and Methods: This study was conducted at Navodaya Medical College and Research Centre for a period of two years. The gastro protective effect of aqueous extract of O. sanctum was studied using model of indomethacin-induced gastric damage and compared with omeprazole. O. sanctum (200mg/kg or 400mg/kg) or omeprazole (10mg/kg) were administered alone (oral gavage) in separate group of rats. Results: O. sanctum showed significant (p < 0.05) protective effect against gastric ulcer induced by indomethacin when compared to control. The gastro-protective effect of O. sanctum was comparable with that of standard drug, omeprazole. Conclusion:O.sanctum having 5-lipoxygenase inhibitory effect, mucoprotective activity and antisecretory effect. Because of this O.sanctum showed significant gastro-protective effect against indomethacin-induced gastric damage.
| » Inflammation Oral | | |
| » INFO-1: Anti-inflammatory Activity of Lisinopril in Albino Rats | | |
Suresha RN, Siddamma Amoghimath1
Department of Pharmacology, JSS Medical College, Mysuru, 1Department of Pharmacology, Gadag Institute of Medical Sciences, Gadag, Karnataka, India
E-mail: [email protected]
Objectives: To evaluate the anti-inflammatory activity of Lisinopril in albino rats. Methods: Eighteen Wistar albino rats weighing around 150-200gms of either sex were randomly selected from central animal facility and divided into three groups. The control group received normal saline 25ml/kg, standard group received Indomethacin 10mg/kg and test group received Lisinopril (3.6mg/kg) orally for six days. The animals were subjected to carrageenan induced paw oedema and cotton pellet induced granuloma model. Results: Lisinopril significantly decreased the mean paw oedema in carrageenan induced paw oedema when compared to control and in cotton pellet induced granuloma Lisinopril decreased the mean granuloma weight when compared to control. Conclusion: Lisinopril showed anti-inflammatory activity when given for 6 consecutive days per orally in albino rats in carrageenan induced paw oedema and cotton pellet induced granuloma model.
| » INFO-2: Anti-inflammatory Activity of Ocimum Sanctum Linn (Tulsi) in Albino Rats | | |
Mirje M
Department of Pharmacology, Gadag Institute of Medical Sciences, Gadag, Karnataka, India
E-mail: [email protected]
Objectives: 1. To evaluate the anti-inflammatory effect of Ocimum Sanctum on acute experimental models in albino rats. 2. To determine the effect of Ocimum Sanctum on the anti-inflammatory profile in response to Indomethacin administration. Materials and Methods: In the present study the aqueous extract of O. sanctum leaves was screened primarily for its anti-inflammatory activity Navodaya Medical College and Research centre, Raichur for a period of two years. In this study, the anti-inflammatory activity of O. sanctum alone and in combination with indomethacin was studied using Carrageenan-induced rat paw edema. Aqueous extract of O. sanctum (200mg/kg or 400mg/kg) was administered alone and in combination with indomethacin (25mg/kg) to separate group of rats and paw volume was measured by plethysmometer and compared with control group. Results: All the test groups showed significant (P<0.05) anti-inflammatory effect in Carrageenan-induced rat paw edema. The reduction of edema by O. sanctum was better than that of the standard anti-inflammatory drug, indomethacin and on co-administration marginally improved the anti-inflammatory profile of indomethacin. Conclusion: O.sanctum possesses significant anti-inflammatory activity probably due to inhibition of both cyclooxygenase and lipooxygenase pathways of arachidonic acid metabolism (dual inhibitory property).
| » INFO-3: Diosgenin, a Steroidal Sapogenin Attenuated Arthritis by Inhibition of Cytokines in Freund's complete adjuvant Induced Arthritis in Rats | | |
Atre BN, Arulmozhi S, Zambare GN, Mahadik KR
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
E-mail: [email protected]
Objective: To evaluate antiarthritic potential of Diosgenin in Freund's complete adjuvant induced arthritis in rats and to study underlying mechanism. Methods: Arthritis was induced in female Albino wistar rats by subplantar injection of 0.1 ml of Fruend's complete adjuvant on day 1. The treatment of Diosgenin (5, 10 and 20 mg/kg) orally once daily started from day 12 till day 28. The body weight, paw volume, pain threshold were determined on day 0, 1, 4, 8, 12, 16, 20, 24 and 28th day. The hematological, biochemical, antioxidant parameters, cytokines level and histopathology were evaluated on day 28. Results: Diosgenin showed significant (p< 0.001) reduction in paw volume and arthritis associated hyperalgesia and allodynia. Diosgenin significantly (p < 0.001) decreased Tumor Necrosis factor-α (TNF-α), Interleukin 1β (IL-1β) and Interleukin-6 (IL-6) level while increasing the antioxidant and biochemical parameters. Diosgenin (400 mg/kg) exhibits anti-arthritic activity by improving the altered hematological milieu (ESR, CRP, WBC, RBC and Hb).The histopathology showed reduced cell infiltration, synovial line thickening and joint erosion of cartilage. Conclusion: TNF-α and interleukin inhibitory activity together with steroidal property of diosgenin may be contributing its antiarthritic potential. These findings reveales diosgenin may be better therapeutic alternative in the treatment of arthritis.
| » INFO-4: Goniothalamin, a Constituent Isolated from Diplocyclos palmatus (L) C. Jeffrey Attenuates TNF-α Level in Freund's complete ADJUVANT induced Arthritis in Rats | | |
Kadam PP, Bodhankar SL
Institute of Pharmacy, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India
E-mail: [email protected]
Objectives: To explore the antiarthritic potential of Goniothalamin, isolated from seeds of Diplocyclos palmatus (L) C. Jeffrey and to investigate underlying mechanisms in Freund's complete adjuvant (FCA) induced arthritis in wistar rats. Methods: Arthritis was induced by injecting 0.1 ml of FCA in right hind paw of wistar rats. The rats were treated with Goniothalamin from day 12 to 28, after induction of arthritis. The study parameters were body weight, paw volume, joint diameter, mechanical and thermal hyperalgesia. On 28th day, serum from each animal was used for estimation of cytokines (TNF-α, IL-1β and IL-6), AST, ALT, ALP, TP and CRP value and whole blood was used for measurement of RBC, WBC, HB and platelet count. Histopathology was performed to measure degree of inflammation in ankle joint. Results: The Goniothalamin reduced paw edema and joint diameter significantly (P<0.001) compared to control group. The Goniothalamin significantly increased mechanical withdrawal threshold (P<0.001), mechanical and thermal hyperalgesia (P<0.001) compared to control. The Goniothalamin dose dependently reduced the increased TNF-α, AST, ALT, ALP, CRP, WBC and platelets. The Goniothalamin significantly increased HB and RBC in arthritic rats. Histopathological observations showed reduced cell infiltration of lymphocytes, synovial lining thickening and erosion of joint cartilage. Conclusion: The current findings demonstrated that Goniothalamin could protect the injured ankle joint from further deterioration and exert its antiarthritic properties through anti-inflammatory and antioxidant effects via inactivating TNF-α signal pathway. This research implies that Goniothalamin may be useful therapeutic agent for the treatment of human arthritis.
| » INFO-5: Pharmacological Studies on the Role of Phosphodiesterase Inhibitors and their Interactions with Nitric Oxide Modulators in Adjuvant Induced Rheumatoid Arthritis in Rats | | |
Pal R, Tiwari PC, Nath R, Pant KK
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, Uttar Pradesh, India
E-mail: [email protected]
Objective: To evaluate anti-inflammatory and immunomodulatory protective role of cAMP/cGMP-PDE inhibitors and their modulation with nitric oxide (NO) modulators in experimental animal model of rheumatoid arthritis. Methods: Wistar rats (200-300 gm, n=6/group) of either sex were used in the study. On day '0' rats were injected with 0.2 ml of complete Freund's adjuvant (CFA) in sub-planter region of right hind paw along with 0.1 ml of squalene to develop RA while controls received only vehicle. Drug treatment alone and in combination with NO modulators was given from day '14' to '28'. Arthritic parameters a) arthritis index, b) ankle diameter c) paw volume and their body weight were noted to evaluate progression of RA on day 0, 7, 14, 21 and 28. On day '28' rats were sacrificed and their blood and paws were collected for TNF-α and IL-10 cytokine estimation, pathological examination and NF-kB expression. Data obtained was analysed using two-way ANOVA followed by Newman-Keul's posthoc test and p<0.05 was considered as significant. Results: It was found that CFA significantly increased arthritis-index, paw volume, ankle diameter and serum TNF-α and NF-kB levels while body weight and serum IL-10 levels was significantly decreased (P<0.05). These CFA-induced changes were significantly reversed by theophylline (10 & 20 mg/kg), p<0.0001; pentoxifylline (5 & 10 mg/kg), p<0.002; rolipram (1 & 2 mg/kg), p<0.05; sildenafil (50 & 50 mg/kg) alone and in combination with L-arginine (100 mg/kg) and or L-NAME (10 mg/kg) in dose dependent manner (p<0.005) in all parameters. Maximum protective effects was observed in theophylline>pentoxifylline>rolipram>sildinafil with L-NAME 10 mg/kg (p<0.001). The data obtained was substantiated by histopathological analysis. Conclusion: Results of this study are suggestive of cAMP/cGMP mediated PDE inhibition may have protective roles in pathogenesis of rheumatoid arthritis. The protective effects of PDE inhibitors were modulated by nitric oxide.
| » Molecular Pharmacology Oral | | |
| » MPO-1: Association of Paraoxnase 1 Gene Polymorphisms and its Activity in Indian Patients with Coronary Artery Disease | | |
Panchal FH, Munshi RP, Kalekar SA, Gandhi SP
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: In the present case control study we have determined the genotype frequencies of PON1 Q192R and L55M in Indian population and also their association between PON activity and lipid markers in patients with coronary artery disease (CAD). Methods: 635 angiographically proven CAD patients from the Cardiology OPD of our hospital and 635 age- matched controls were enrolled for the study. Paraoxonase gene polymorphism at codon 192 and 55 were analyzed by PCR-RFLP. Allele frequencies were compared in patients and controls using Chi-square test. Serum activity of PON1 was determined towards PON substrates and lipid profile and apolipoprotein A1 were also analyzed. Results: The variant allele frequency of R& M in controls and patients were 28% &37% and 20% & 21% respectively. Phenotypically, Paraoxanase activity was significantly lower in CAD patients as compared to controls, whereas, genotypically, PONase activity was significantly lower in QQ followed by QR and RR in patients and controls.PON1 activity correlated positively with HDL Cholesterol and Apo 'a' levels (r=0.38 and 0.38). At PON1-192 locus, there was a significant difference between patients and controls leading to significant Odds ratio for RR genotype [OR =2.40; CI:1.58-3.64]. However PON1-55 locus did not show significant differences between patients and controls [Odds ratio for MM was 1.16, CI: 0.63-2.13]. Conclusion: The study shows that PON1-192R allele is strongly associated with CAD patients and also affects serum PON1 activity toward paraoxon, which implies a higher likelihood of development and/or progression of CAD in Indian population.
| » MPO-2: Analgesic Activity of Fosinopril in Albino Mice | | |
Amoghimath S, Mruthyunjay Mirje, Suneel Majagi
Gadag Institute of Medical Sciences, Gadag, Karnataka, India
E- mail: [email protected]
Objective: To evaluate the analgesic activity of Fosinopril in albino mice and to compare with that of standard drug Pentozocine in albino mice. Methods: 54 Swiss albino mice of either sex of average weight 25-30 g, aged 3-4 months were used in the experiments and the rats were divided into 9 groups containing six animals (n=6) in each group (control, Standard and test group). The control group received distilled water (25ml/kg body wt.) per orally, test group received Fosinopril (5mg/kg/day) per orally, Standard group received Pentozocine (30mg/kg/day) intra peritoneal. The test drug and the control were given 2 hr before the evaluation, while the standard drug Pentazocine was given 15 min before the evaluation. The analgesic evaluation was done by conducting Writhing model, Eddy's hot plate model and tail clip model. The decrease in the number of writhes in Writhing method, delay in the reaction time in the tail clip and Eddy's hot plate model were considered as analgesic activity. Results: The test drug Fosinopril decreased the number of writhes in writhing method and delayed the reaction time in tail clip method and Eddy's hot plate method. Conclusion: Fosinopril showed analgesic activity compared to control in thermal, chemical and mechanical method in Swiss albino mice.
| » MPO-3: Phytopharmacological and Antimicrobial Evaluation Studies of Rudrakasha Bead: A Promising Natural Remedy | | |
Singh Satnam, Singh Balbir, Kaur Amandeep, Singh Gurinder
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Adesh University, Bathinda, Punjab, India
E-mail: [email protected]
Abstract: According to the World Health Organization, approximately 80% of the world's population in developing countries relies on traditional medicines, which are mostly derived from plants, for their primary health care. Epidemiological studies have shown that many of the phytochemicals from medicinal plants possess anti-inflammatory, antiatherosclerotic, antitumor, antimutagenic, anticarcinogenic, antibacterial and antiviral activities. These are also associated with reduced risks of cancer, cardiovascular disease, diabetes and lower mortality rates of several human diseases (Ozkan et al. 2016). Despite the easy availability of antibacterial agents, appearance of resistant and multiresistant strains has projected the need of suitable and potent drug/remedy from nature based sources. Objective: To explore & evaluate the antimicrobial potential of Rudrakasha against Pathogenic bacterial strains. Methods: Various crude extracts of dried fruits of E. ganitrus namely Ethanolic extract (EE), Chloroform extract (CE), Petroleum either extract (PE) and Water extract (WE) have been obtained with soxhlet apparatus were found to have Phytostroles, alkaloids, Flavonoids, Carbohydrates, Tannins and Proteins. All extract were used to explore the antimicrobial potential against Pathogenic bacterial strains. The anti bacterial activity of various extracts of E. ganitrus were tested against reference strains Klebsiella pneumoniae, and Enterococcus faecalis. For each concentration of all the four extracts (EE, CE, PE & WE), a zone of inhibition was observed and diameter of the same was measured both in case of Klebsiella pneumoniae, and Enterococcus faecalis. Results: The three extracts (EE, CE & WE) have shown inhibitory activity against the reference strains to remarkable extent. The EE & CE extracts has shown the strong inhibitory effect as compared to water extract. Conclusion: The present study has lead to the attainment of successful result of antibacterial activity against both the common pathogenic strains of bacteria.
| » MPO-4: Molecular Mechanisms Involved in the Protective Effects of Withaferin A in Lung Fibrosis | | |
Chandraiah Godugu, Swarna Bale
Department of Regulatory Toxicology, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India
E-mail: [email protected]
Objective: Pulmonary fibrosis (PF) is a chronic lung disease with only two FDA approved drugs available clinically. Inadequate therapy motivated us to explore the effect of vimentin inhibitor Withaferin A, as an anti-fibrotic agent against TGF-β1 induced in vitro fibrosis and Bleomycin induced in vivo fibrosis with an emphasis on epithelial to mesenchymal transition (EMT), extracellular matrix (ECM) deposition, inflammation and angiogenesis. Methods: Alveolar epithelial cells and human fetal lung fibroblasts were stimulated by TGF-β1 and treated with Withaferin A (0.25, 0.5 and 1 μM concentrations) to explore possible mechanisms of anti-fibrotic effects. Bleomycin at a concentration of 2 IU/kg was oropharyngeally aspirated to induce fibrosis in murine model and therapeutic potential of Withaferin A (2 and 4 mg/kg) was assessed by initiating treatment one day after Bleomycin administration and continued for 28 days. All the parameters related to PF and molecular studies were performed at the end of treatment period. Results: Withaferin A treatment reduced the progression of PF by modulating EMT related cell markers both in vivo and in vitro. Withaferin A further ameliorated the expression of inflammatory cytokines and attenuated the expression of pro-fibrotic and fibrotic proteins in Bleomycin induced PF by modulating Smad 2/3 signaling. The expression of angiogenic factors in HFL1 cells were also inhibited by Withaferin A. Conclusion: Withaferin A treatment suppressed the expression of pro-inflammatory, pro-fibrotic and pro-angiogenic mediators; also reduced the deposition of ECM proteins. In a nutshell, Withaferin A could probably prove as an efficient and potential therapeutic against PF.
| » MPO-5: Role EPAC1, PKA and POPDC1 in Gastric Cancer cell Migration and Proliferation | | |
Palasuberniam P, Paramanantham Y1
Department of Biomedical Sciences and Therapeutics, Faculty of Medicine and Health Sciences, University Malaysia Sabah, Sabah, Malaysia, 1School of Medicine, University of Aberdeen, Aberdeen, Scotlan, UK
E-mail: [email protected]
Objective: Being the highest infectious cause of cancer, gastric carcinoma possesses invasive metastatic properties resulting in high mortality rates. Relatively 90% of malignancy related morbidities and mortalities is credited to cancer metastasis of solid primary tumours to secondary sites. The objective of this project was to determine the influence of cAMP downstream mediator proteins, EPAC, PKA and POPDC1, on migration and proliferation of a stage IV gastric carcinoma cell line (N87WT cells). Methods: Protein expressions was analyzed using immunocytochemistry and confirmed using Western blotting technique. To assess single cell and cell population levels of migration status of the N87WT and N87 POPDC1 knockdown cell lines, single cell motility and Boyden migration assays was conducted. Cell proliferation was determined using an alamarBlue® Proliferation Assay using different treatments. Results: Activation of PKA stimulated migration of N87WT cells in the Boyden transwell migration and single cell migration assays. There was a reduction in migration of these cells in EPAC1 activation and in a non-selective cAMP analogue. PKA triggered migration in both migration assays whereas POPDC1 activation reduced migration, but activated proliferation of N87WT. EPAC and PKA treatments showed no change in cell proliferation. Administration of a non-selective cAMP analogue in POPDC1 knock down N87 cells showed that EPAC1 or PKA (or both) functions by balancing out the response of POPDC1 in regulating proliferation of N87WT. Conclusion: Downstream mediators of second messenger cAMP, EPAC1, PKA and POPDC1, play a role in N87WT cell migration and proliferation. Analogues of these proteins play an up-and-coming target in the management of gastric cancer cell invasion and metastasis.
| » Neuro Oral | | |
| » NPO-1: Neuroprotective Role of Glycyrrhiza Glabra in Cerebral ischemia Reperfusion Induced Alteration in Rats | | |
Pandey Akchhara, Purohit Suresh, Trigunayat Anshuman
Neuropsychopharmacology Laboratory, Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
E-mail: [email protected]
Objective: The current study explores the neuroprotective role of Glycyrrhiza glabra; categorised as medhyarasayana in Indian system of Medicine, on acute cerebral ischemia reperfusion injury induced cerebral oxidative stress in rats. Materials and Methods: Acute cerebral ischemia reperfusion technique was used to induce cerebral oxidative stress. Acute injury was induced by blocking bilateral common carotid arteries for 30 minutes and reperfusion for 45 minutes in Charles foster strain of albino rats. The present study investigates the role of Glycyrrhiza glabra in cerebral oxidant and antioxidant status. The biochemical parameters [lipid peroxidation, superoxide dismutase (SOD) activity & total tissue (T-SH)] were estimated to assess the neuroprotective potential of the given drug. Results: Glycyrrhiza glabra pre-treatment altered the cerebral insult induced biochemical parameters. Conclusion: The results suggest that Glycyrrhiza glabra maybe useful in cerebral ischemia reperfusion injury.
| » NPO-2: Protective Effects of Interleukin-1 Inhibition in Renovascular Hypertension and Hyperhomocysteinemia Induced Vascular Dementia in rats | | |
Aggarwal H, Sharma B1
Department of Pharmacology, KIET School of Pharmacy, KIET Group of Institutions, Ghaziabad, 1Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India
E-mail: [email protected]
Background: Endothelium serves one of the most important purposes of regulating the caliber of the blood vessels supplying vital organs. Failure of ACh mediated vasodilatation due to endothelial damage is referred to as endothelial dysfunction (ED). ED contributes by devoiding off the organs of their share of blood and nutrition which later culminates to demented states of vascular origin. Vascular dementia (VaD) is second most debilitating dementing condition after Alzheimer's disease. VaD is very closely associated with metabolic disturbances viz. hyperhomocysteinemia (Hhcy), hyperlipidemia, hypertension (HT) and diabetes; these conditions damage the endothelium via excessive oxidative stress, baric and osmotic insults. HT and Hhcy have vast epidemiology and multiple channels of development, the present huge risk to the population and have been reported to cause organ damage with the neurovascular and cardiovascular system at high risk. VaD still has no approved pharmacological intervention for its treatment or management and hence puts huge economic burden. Objective: The present study was designed to investigate the possible beneficial role of Interleukin-1 inhibition and donepezil administration in renovascular hypertension and Hhcy induced endothelial dysfunctioning and VaD in rats. Methods: Renovascular hypertension was induced by Goldblatt technique (2K1C method) and Hhcy by L-methionine administration (1.7g/kg, p.o. per day). Learning and memory were assessed on Morris water maze (MWM) and Attentional Set Shifting Task (ASST) apparatus. Locomotion and muscle coordination were assessed by rota-rod and inclined beam test apparatus. Mean arterial blood pressure assessment was carried out NIBP monitoring system (AD Instruments, Australia). Vascular integrity assessment was done by testing endothelial function through aortic ring preparation. Biochemical estimations were performed to assess oxidative stress (serum nitrite/nitrate, aortic superoxide anion, serum and brain thiobarbituric acid reactive species-TBARS, serum and brain glutathione-GSH, brain catalase activity and brain superoxide dismutase-SOD), serum homocysteine, lipid and brain calcium level. The degree of cerebral edema, blood-brain barrier integrity, and brain infarct development was also assessed through brain water content, Evans blue More Details extravasation, and TTC staining respectively. Results: 2K1C procedure significantly raised the MABP and animals with MABP >160mm Hg were selected for the study, similarly, L-methionine administration elevated serum Hhcy levels and animals with homocysteine levels >10μM were selected for the study. Hypertensive and hyperhomocysteinemic rats performed poorly on MWM as well as on inclined beam apparatus. The animals also showed impaired learning through ASST and had a significant elevation of oxidative stress markers and brain calcium along with vascular endothelial dysfunction. Treatment with diacerein and donepezil significantly attenuated hypertension and Hhcy induced learning and memory deficits, endothelial dysfunction, changes in various biochemical parameters and brain calcium; however, no effects were observed on MABP and serum homocysteine levels. The degree of cerebral edema and brain infarct were also curbed in tandem with protection to blood-brain barrier integrity. Conclusion: Diacerein and donepezil are advocated to be considered as potential therapeutic agents for targeting Interleukin-1 for treatment of hypertension and Hhcy induced endothelial dysfunction and VaD.
| » NPO-3: Antidepressant-like Activity of Flunarizine in Learned Helplessness Test in Albino Rats | | |
Shinde VS, Yegnanarayan R, Doshi KP, Agrawal AB
Department of Pharmacology, Smt. Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India
E-mail: [email protected]
Objectives: Objective of the present study was to test antidepressant activity of flunarizine by using learned helplessness test in albino rats. Materials and Methods: The study was conducted using 24 albino rats (n=6). Prior approval of Institutional Animal Ethics Committee was obtained. Antidepressant activity of normal saline (0.1 ml/100g), fluoxetine (10 mg/kg, intraperitoneally (ip)), and flunarizine (2 and 10 mg/kg, ip) was evaluated by using learned helplessness test in rats. On first day, learned helplessness was produced individually in each rat, by exposure to electric shock (0.7 mA) for 1 h on a schedule of 10s of shock/min. On the second day, 30 minutes after administration of all test drugs antidepressant activity was evaluated in each rat, by using learned helplessness apparatus. Each rat underwent ten trials with an inter-trial interval of 20s. Number of failures to escape was observed in all the four groups. The data was analyzed by Mann-Whitney U test and P < 0.05 was considered significant. Results: Number of failures to escape was significantly reduced in rats of two groups i.e. fluoxetine (10 mg/kg, i.p) and flunarizine (10mg/kg, i.p) as compared to the normal saline (P < 0.05). Low dose of flunarizine (2 mg/kg) did not significantly reduced the number of escape failures (P>0.05). Number of escape failures was reduced in both fluoxetine and flunarizine (10mg/kg, i.p) groups and was statistically non significant when compared with each other (P>0.05). Conclusion: The results of the present study indicate antidepressant like activity of flunarizine in albino rats.
| » NPO-4: Quercetin Protects Doxorubicin's Anti-tumor Potential and mitigates its Complications in Mammary Carcinoma Rats | | |
Ramalingayya GV, Karthik Gourishetti, Pragnya Cheruku, Nandakumar K, Niteshkumar, Rekha Shenoy
Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
Background: Chemotherapy induced cognitive impairment (CICI) is one of the major concerns in breast cancer (BC) survivors. Till date, no interventions are approved for this condition. Quercetin (QRC) is known for its pleiotropic properties and known to inhibit oxidative stress in brain, neuro-inflammation and improves cognitive function. The objective of the present study is to evaluate the protective effect of QRC against doxorubicin (DOX) induced cognitive dysfunction in NMU (N-nitroso, N-methyl urea) induced mammary carcinoma in rats. Methods: Mammary carcinoma to SD rats were induced by injecting NMU (50 mg/kg, i.p.). Following the induction of mammary carcinoma (after 8 weeks of NMU injection), DOX was administered at 2.5 mg/kg, i.p. once every 5 days for 50 days. QRC was given daily at a dose of 50 mg/kg, p.o. started one week before the first DOX injection. Following which the rats were subjected to behavioral testing in (novel object recognition test) NORT followed by MWM (Morris water maze test) and assessment of tumor weight.Results: In NORT, mammary cancer rats did not show impairment in episodic memory where as DOX treated mammary cancer rats showed significant decrease in RI and DI indicating impairment in object recognition and recall. Treatment with QRC protected these changes against DOX. Further it did not influence the anticancer potential of DOX against mammary cancer growth. In MWM test, DOX control animals performed significantly less on acquisition as well as retention parameters. Treatment of QRC protected these spatial memory deficits induced by DOX. Mammary carcinoma bearing rats did not show any impairment of spatial memory deficits either for acquisition or retention parameters. Further QRC also protected the myelosuppression induced by DOX in the mammary carcinoma rats. Conclusion: From the present study, we can conclude that QRC can be indicated as a nutritional supplement along with DOX to prevent its complication without affecting its anti-tumor potential of it.
| » NPO-5: Effect of Nalbuphine Co-administration on Tryptophan Hydroxylase in Morphine Dependent Rats | | |
Raghav R, Jain R, Roy TS1, Dhawan A, Kumar P1
National Drug Dependence Treatment Centre, Ghaziabad, Uttar Pradesh, 1Department of AnatomyAll India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
[email protected]
Background: Serotonin plays an important role in stress-related psychiatric disorders and drug abuse which can inhibit the dorsal raphe nucleus-serotonin system. Tryptophan hydroxylase (TPH), the rate-limiting enzyme in Serotonin synthesis, plays an important role in the survival of serotoninergic neurons. The present study evaluated the morphine induced alteration in brain TPH and the effect of nalbuphine treatment on these alterations in morphine dependent rats. Methodology: Male adult Wistar albino rats (170-175gms, N=160) were made physically dependent by administrating increasing dose of morphine and withdrawals were precipitated with naloxone. Nalbuphine was co-administered acutely and chronically in variable doses (0.1, 0.3, 1.0, 3.0 mg/kg, i.p.) with morphine. Brains were dissected out and were snap-frozen in liquid nitrogen for estimating protein and m-RNA levels of TPH. Results: Protein and mRNA levels of TPH were significantly increased with increased morphine exposure whereas levels were significantly decreased during withdrawal. Treatment with chronic co-administration of nalbuphine produced a marked increase in TPH levels whereas no effect was observed with acute dose of nalbuphine. Conclusion: These findings contribute to better understanding the influence of serotonin and nalbuphine treatment on opiate withdrawal. The pattern of results presented here provide a support that nalbuphine may be good adjuvant to morphine and could have great potential for the development of new therapies to prevent opiate addiction. (Supported by Indian Council of Medical Research, Govt. of India and Rusan Pharma Ltd).
Keywords: Morphine, nalbuphine, serotonin, tryptophan hydroxylase, withdrawal
| » NPO-6: A Study to Evaluate the Adherence Pattern among Patients of Epilepsy on Anti-epileptic Drugs in a Tertiary Care Hospital | | |
Khanna S, Bala S, Singh Y1, Dhasmana DC, Sharma T, Kalra J
Department of Pharmacology and Neurology, 1Himalayan Institute of Medical Sciences, Dehradun, Uttrakhand, India
E-mail: [email protected]
Introduction: AED non-adherence is highly prevalent and is associated with increased morbidity & mortality. Yet, little is known about the factors that contribute to non-adherence and extent of non-adherence and its association with seizure control. Objective: Evaluation of adherence inpatients on anti-epileptic drugs. Materials and methods: This was a prospective, cross sectional study enrolling 100 patients suffering from epilepsy in the department of pharmacology in collaboration with department of neurology for a period of 6 months. Permission from the institutional ethics committee was taken. Written Informed consent was taken from all the patients. Patient adherence and persistence in long term continuation of treatment was assessed using the Modified Morisky Adherence Scale (MMAS). Results: Among all the participating patients (100) 69% were males and 31% were females. Mean age of patients was 28.78 ± 15yrs.GTCS was the commonest seizure (58%) followed by partial seizures (41%) and unclassified seizures (1%). Levetiracetam (37%) was the commonest drug prescribed, followed by valproic acid (24%), carbamazepine (19%), oxcarbazepine (14%), phenytoin (5%), phenobarbitone (1%).45%participants had high,19% medium and 36% low adherence rates respectively. Number of Pateints who were strongly adherent to AEDs were carbamazepine(10/ 19), Phenytoin(1/ 5), levetiracetam(17/ 37), oxcarbazepine (5/ 14), phenobarbitone (1/ 1), valproic acid(11/24). Among the patients who were highly adherent (31 ) have education level above 12th pass and 14 participants were below 12th pass. 19 patients were of medium adherence (2 ≥12th, 17 < 12th) & 36 low adherence group (4 ≥ 12theducation ,32 < 12th education). Conclusions: Education level and patient counseling help in improving the adherence in patients.
Keywords: Adherence, epilepsy, modified morisky adherence scale
| » NPO-7: Neuroprotective Effect of Rosiglitazone, PPARγ Agonist, in HFD Induced Insulin Resistance and Associated Alzheimer's Type of Dementia | | |
Sarathlal KC, Sruthi Ramagiri, Deepak Chitkara, Rajeev Taliyan
BITS, Pilani, Rajasthan, India
Introduction: Type-2 diabetes mellitus (DM) and insulin resistance, is known to reduced sensitivity of target tissues to the favourable effects of insulin. In the recent past, numerous studies have demonstrated that type-2 DM and insulin resistance increases the risk of developing neurodegenerative diseases including Alzheimer's disease (AD). It was believed that altered glucose metabolism, inflammation, and insulin resistance are common key pathological features of both DM and AD. This study has been designed to investigate the role of rosiglitazone in high fat diet (HFD) induced DM and Alzheimer type of dementia in mice. Materials and Methods: Mice were subjected to normal diet or high fat diet for a minimum of 8 weeks. To evaluate the cognitive functions, a battery of behavioural parameters were performed including, passive avoidance task, object recognition task and morris water maze test. Further, oxidative stress markers like malonyldialdehyde (MDA), glutathione (GSH), superoxide-dismutase (SOD) and pro-inflammatory cytokines like tumour necrosis factor-α (TNF-α) and interleukin-6 (IL-6) and brain derived neurotrophic factor (BDNF) were measured in hippocampus homogenates. Results: HFD fed mice showed significant characteristic features of insulin resistance along with severe deficits in motor and cognitive abnormalities. However, mice treated with rosiglitazone showed improvement in insulin resistance dose dependently. Moreover, rosiglitazone treatment markedly ameliorated the cognitive and motor performance. Treatment with rosiglitazone attenuated pro-inflammatory cytokines-TNF-α and IL-6 levels and oxidative marker (MDA) while increased antioxidant enzymes GSH and SOD levels when compared with HFD fed animals. Moreover, these changes occurred concurrently with an increased BDNF levels. Conclusion: Based upon these results, it is suggested that rosiglitazone can exert beneficial effects against HFD induced insulin resistance and associated AD.
| » Ocular Pharmacology Oral | | |
| » OPO-1: Role of Impression Cytology as a Diagnostic Technique to Find Ocular Surface Disease in Patients of Glaucoma on Anti Glaucoma Therapy | | |
Das S, Singh G
Government Medical College, Baba Farid University of Health Sciences, Patiala, Punjab, India
E-mail: [email protected]
Objective: To study changes in ocular surface of patients of glaucoma on anti glaucoma therapy using Impression Cytology, Schirmer test, Fluorescein staining and Tear Film Breakup Time Test. Methods: It was an observational, interventional, prospective, randomised, comparative study, conducted at Out Patient Department of Ophthalmology at Rajindra hospital, Patiala. 60 cases were administered anti glaucoma drugs and other 30 controls were without any sort of medication. Schirmers test, Fluorescein staining, Tear Film Break up Time were evaluated at baseline and, conjunctival epithelium's smear were collected on Cellulose Acetate Filter Paper. Specimen were transferred to glass slide and fixed with alcohol. Slides were further stained with H/E and PAS stains and were evaluated according to Nelsons and Adams grading. Results: Out of 60 cases, 33 and 27 were male and female respectively (male: female- 1.22: 1), whereas, for 30 controls, 16 and 14 were male and female respectively (male: female- 1.14:1). Majority of Cases and Controls belonged to age group of 51-60 years and 41-50 years respectively. On comparing TBUT and Schirmer test with Cytology, it was seen that majority of cases having an abnormal cytology had TBUT and Schirmer value of <5 seconds and <5 mm respectively On comparing mean of Conjunctival Impression cytology with that of TBUT and Schirmer, it was found that p value was highly significant (p <0.01). Conclusion: Conjunctival Impression Cytology gave a better result in order to diagnose Ocular Surface Disorder caused as a result of chronic topical anti glaucoma medications.
| » OPO-2: Comparative Efficacy and Tolerability of Prostaglandin Analogue Drugs among Indian Glaucoma Patients | | |
Virani S, Rewri P1
Departments of Pharmacology and 1Ophthalmology, Maharaja Agrasen Medical College, Hisar, Haryana, India
[email protected]
Objective: To compare efficacy and tolerance of topical prostaglandin analogue drugs among patients of glaucoma. Methods: The study recruited diagnosed cases of primary glaucoma using any of commercially available prostaglandin analogue topical drugs for control of intra-ocular pressure (IOP). We included three drugs-bimatoprost (0.1%), latanoprost (0.005%) and travoprost (0.004%). Efficacy of these drugs was calculated by percentage reduction of IOP from baseline IOP at 1,4 and 12 weeks. Tolerability was assessed by recording adverse events either highlighted by patients or noted as clinical sign by treating ophthalmologist. Results: A total of 78 patients of glaucoma, with mean age of 61 years were included. The IOP reduction ranged between 18-43% from baseline at 12 weeks. Hyperemia and Meibomian gland More Details dysfunction (MGD) seen was most often with bimatoprost (0.1%). Conclusion: The relative efficacy of prostaglandin analogues drugs for IOP reduction is similar but tolerability of these drugs varies among Indian patients.
| » OPO-3: A Comparative Study of Efficacy and Safety of Moxifloxacin 0.5% versus Ofloxacin 0.3% Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis | | |
Jayanthi CR, Darshini MB
Department of Pharmacology, Bangalore Medical College and Research Institute, RGUHS, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: To assess efficacy and safety of moxifloxacin 0.5% versus ofloxacin 0.3% ophthalmic solution in the treatment of bacterial conjunctivitis from baseline to day 8. Methods: A prospective, open label, randomized study was conducted in Ophthalmology department from July 2017 - November 2017 at Minto Eye Hospital, BMCRI. Adult patients diagnosed with Bacterial conjunctivitis, fulfilling inclusion criteria were randomly assigned into two groups receiving either moxifloxacin 0.5% (3 times a day) or ofloxacin 0.3% (4 times a day) for 7 days with a test-of-cure (TOC) at Day 8. Efficacy was assessed by reduction in ocular symptoms using Clinical cure rate at day 4 and 8 from baseline. Microbiological eradication of baseline bacterial infection was assessed by conjunctival swab culture at Day 8. Safety was assessed by monitoring treatment emergent adverse effects. Results: A total of 60 patients were enrolled and randomised into 2 groups of 30 each. 86.6% of the patients in moxifloxacin group and 83.3% in ofloxacin group were clinically cured at day 4 (p=0.02) and TOC-visit (p=0.78). Microbiological eradication was observed in 96.6% of patients in moxifloxacin group and 93.3% in ofloxacin group. Ocular adverse events (eye pain, eye irritation) were the most common adverse events, with majority being of mild severity in both the groups. Conclusion: A comparable clinical cure and microbiological success rate was achieved in both the groups with good tolerability profile. However, moxifloxacin 0.5% showed early resolution of clinical symptoms as early as day 4 with less frequent dosing in patients with bacterial conjunctivitis.
| » Endocrine Pharmacology Oral | | |
| » EPO-1: Synthesis Characterization and Pharmacological Evaluation of Novel Pyrazolone Derivatives for Antidiabetic Activity | | |
Vijay Kumar M, Revanasiddappa BC
Department of Pharmaceutical Chemistry, NGSM Institute of Pharmaceutical Sciences of Nitte University, Mangalore, Karnataka, India
E-mail: [email protected]
Objective: i) To synthesize and Novel Pyrazolone derivatives ii)characterization by IR, NMR and Mass spectra analysis iii) Evaluation of the pyrazolones for antidiabetic activity in STZ induced Diabetic model. Methods: Synthesis of substituted ethyl-2-aryl hydrazono-3-oxobutyrates all the new compounds were characterized by IR, 1H-NMR, Mass and elemental analysis were used as precursors for the synthesis of substituted 3-methyl-5-pyrazolone. Wister albino rats (weighing 175-200 g) of either sex were used during this study. Ethical clearance for usage of the animals was obtained from the Institutional animal ethical committee Certificate reference no: 115/1999/CPCSEA prior to the beginning with the project work. The toxicities of Pyrazolones were determined as per OECD guidelines No 425.Antidiabetic activity was carried out by STZ (Streptozotocin induced diabetic model) which lasts for 14days. Results: The results of present work has shown the better anti-diabetic activity of Synthesized Pyrazolones for the compound S1-S5 among the five compounds on 15th day compounds are able decreased the elevated blood glucose levels like standard(Glibenclamide) ,compound S3 and S4 shown 131.8 ± 12.11 and 148.8 ± 10.83 , 204.8 ±7.03 respectively and biochemical parameters also regulated in experimental rat models. Conclusion: The synthesized compounds were confirmed with the different spectral studies and shown acceptable antidiabetic activity especially S3 and S4 found to be potent.
Keywords: Antidiabetic, blood glucose, pyrazolones, streptozotocin
| » EPO-2: Comparative Study to Evaluate Efficacy and Safety of Metformin and Voglibose Combination versus Metformin and Pioglitazone on HOMA-IR, HbA1c and Serum Insulin | | |
Faheem M, Deepak SB
Department of Pharmacology, MGM Medical College, MGM University, Navi Mumbai, Maharashtra, India
E-mail: [email protected], [email protected]
Aim and Objectives: 1. To compare effect of Metformin and Voglibose versus Metformin and Pioglitazone on HOMA-IR, HbA1c, Serum Insulin in Type 2 DM Patients, 2. To compare the safety of Metformin and Voglibose combination versus Metformin and Pioglitazone in Type 2 DM Patients as per adverse effects reported by patients. Materials and Methods: Study Design: (1)Comparative, Prospective, randomized, Open-label, Single Center, Parallel group. (2) Group I: Metformin + Voglibose. (3) Group II: Metformin + Pioglitazone. Inclusion Criteria: (1) Male or female patients between 18 to 60 years of age with Type 2 DM diagnose according to ADA criteria (FBS ≥ 126 mg/dl and 2hrs PPBS 200 mg/dl). (2) HbA1c between 6-8%. Exclusion Criteria: (1) Patients with Type I DM. (2) Patients with severe cardiac, liver and renal disease. Results: After 3 months it was showed that Group I and Group II reduced FBG, PPBG and HbA1C significantly but Group II showed highly significantly change in FBG but PPBG highly significantly change in Group I whereas the difference in mean percentage change in HbA1C was not significant in both group. HOMA-IR and Serum Insulin significantly change in Group II than Group I. Also, fall in total cholesterol, TG, LDL and VLDL was significantly greater with Group II than Group I. Few side effects were recognized with Group I and not with Group II. Conclusions: Group I and Group II were equally effective in lowering HbA1C levels yet Group II showed better results in improving FBG, HOMA-IR, Serum insulin and lipid profile as compared to Group I. Whereas Group I showed better results in improving PPBG. Group II had minimal side effects as compared to Group I.
| » EPO-3: Carbimazole Induced Insulin Autoimmune Syndrome, a Rare Cause of Non-diabetic Hypoglycemia: Case Report | | |
Pant V, Bhandari B1, Bajracharya SR1, Baral.S2
Departments of Clinical Biochemistry, 1Clinical Pharmacology and 2Internal Medicine, Institute of Medicine, Tribhuwan University, Kathmandu, Nepal
E-maul: [email protected]
Objective: To report insulin autoimmune syndrome (IAS) a rare cause of non-diabetic hypoglycemia. Methods: Here we describe a clinical course of a patient with autoimmune hypoglycemia including outcome of laboratory workup and imaging along with the therapeutic intervention and follow up. Results: A 59 years old female, presented with history of multiple episodes of neuroglycopenic symptoms for two weeks occurring few hours after taking meal without prior exogenous insulin or oral hypoglycemic agents therapy. Patient was on carbimazole therapy for hyperthyroidism. On evaluation of hypoglycemia, there was significant rise in insulin 112.53 mU/L (3-25 mU/L) and C-peptide 19.38ng./mL (0.8-3.8 ng/mL) concentration The molar ratio of insulin to C-peptide was more than one. Abdominal contrast CT scan excluded insulinoma. Antinuclear antibody test was negative. ACTH stimulation test demonstrated adequate cortisol response. There was high level of insulin auto antibodies >300 U/mL Specific genetic testing for HLA typing could not be done due to financial constraint. Carbimazole was stopped immediately and radio ablation was done for hyperthyroidism. There was improvement in symptoms and, no hypoglycemic episodes occurred during one year of follow up. Conclusion: Although a rare cause, IAS should be considered in differential diagnosis of unexplained hypoglycemia in patients taking carbimazole. Appropriate algorithm knowledge for the evaluation of non-diabetic hypoglycemia is required for management of such cases.
| » EPO-4: Evaluation of Anti-diabetic Activity of Combination of Beta Caryoplhyllene and L- Arginine in Streptozotocin Induced Diabetic Rats | | |
Kumawat VS, Kaur G
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: Beta caryophyllene (BCP) is cannabinoid receptor 2 (CB2) agonist with insulinotropic and L- arginine (LA) shows and beta cells regeneration activity. Both drugs shows anti-inflammatory and anti-oxidant activity individually also. The combination of BCP and LA could work as potential treatment of diabetes mellitus. The aim of present study was to evaluate anti-diabetic potential of BCP and LA against streptozotocin (STZ) induced type 1 diabetes mellitus. Materials and Methods: Type I Diabetes was induced by single intraperitoneal injection of Streptozotocin (55mg/kg). Group I and II was normal and diabetic control whereas group III was treated with standard ( metformin 200 mg/kg oral) and group IV (BCP 300 mg/kg oral), group V (LA 150 mg/kg oral) and group VI treated with combination of both ( BCP 200 mg/kg and LA 100 mg/kg oral) once daily. At the end of 42 days plasma was analyzed for glucose, SGOT, SGPT, Cholesterol, triglycerides. Anti-oxidant parameters (SOD, Catalase, Lipid peroxidation) and histopathological study of pancreas was performed. Results: The diabetic rats showed significantly (< 0.0001) increased levels of cholesterol, SGOT, SGPT, glucose and triglycerides. However, once-daily 42-day treatment with the combination of both, led to significant improvement in the lipid parameters compared with the BCP and L-A. Significant decreased in anti-oxidant parameters observed in combination group as compare to BCP and L-A. Histopathological study shows that combination treatment improved damaged structure of pancreatic tissues. Conclusion: Combination of BCP and L-A shows significant anti-diabetic effect than that of alone, by this finding we will conclude that combination of both will be rational treatment for diabetes.
| » Pharmacokinetics Oral | | |
| » PKO-1: Pharmacokinetic and Pharmacodynamic Drug Interaction between Telmisartan and Glimepiride-metformin Combination in Rats/ Rabbits | | |
Anil Kumar KV, Beere Nagaraju
Department of Pharmacology, Visveswarapura Institute of Pharmaceutical Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objective: The aim of the study reported here was to evaluate pharmacokinetic and pharmacodynamic interactions between telmisartan and glimepiride with metformin therapy in rats/ rabbits. Methods: Studies were conducted in normal rats; alloxan induced diabetic rats and normal rabbits with oral administration of selected doses of glimepiride + metformin; telmisartan and combination in single and multiple dose treatments of glimepiride + metformin & telmisartan with adequate wash out periods in between treatments. Blood samples were collected from rats and rabbits at different time intervals and were analyzed for blood glucose by GOD/POD method and serum glimepiride levels by HPLC method. Results: Telmisartan alone did not produce significant hypoglycemia when administered alone and did not alter the hypoglycaemic effect produced by the glimepiride + metformin both in single and multiple dose treatments in normal rats, diabetic rats and slightly elevated in normal rabbits. There was no significance difference of insulin levels in both single and multiple dose treatments. The serum glimepiride levels were slightly altered with both single and multiple dose treatment with telmisartan. AUC and AUMC were found to be increased during single and multiple dose treatment of telmisartan along with glimeperide. Conclusion: In conclusion, the combination might be safe with respect to its hypoglycemic effect; so the doses of glimepiride + metformin and telmisartan are advised to be safe when coadministered in a clinical situation.
| » PKO-2: Pharmacokinetic and Pharmacodynamic Interaction of Eugenia jambolana extract with Sitagliptin, A DPP-4 Inhibitor | | |
Laddha AP, Vora A, Varghese A, Kachwala Y
Department of Pharmacology, Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Eugenia jambolana (EJ) is an Indian traditional herb widely used for the treatment of diabetes for considerable years. This herb is globally marketed as single or multi herb formulations. Many diabetes patients consume EJ extract in addition with conventional oral hypoglycemic drugs. This calls for a need to assess risks versus benefit of this co-administration. Methods: In present investigation, pharmacodynamic and pharmacokinetic interactions of aqueous extract of EJ seeds at the dose of 400 mg/kg is studied with 100 mg/ kg of oral hypoglycaemic drug sitagliptin (SITA) by co-administrating them for 28 days in streptozotocin (STZ) induced diabetic rats. Results: The pharmacokinetic parameters, Cmax and AUC of SITA were determined using HPLC-ESI-MS/MS and it was found that SITA levels were significantly reduced in combination treatment group at the end of 28 days. However, the study of pharmacodynamic parameters on showed that despite low levels of SITA, the combination demonstrated a significant reduction in blood glucose level in comparison to plain drug and plain extract administered groups. Conclusion: Based on the in-vivo study, it can be hypothesized that EJ seed extract induced cytochrome metabolizing enzymes and SITA was found to be the favourable substrate. This herb drug interaction in animal model emphasizes the need for further studies in the clinical set up to warrant the use of EJ herbal extract with antidiabetic drug, SITA.
Key words: Eugenia jambolana, pharmacokinetic-pharmacodynamics interaction, sitagliptin
| » PKO-3: A Study of Drug-drug Interactions in Elderly In-patients in Medicine Department at a Tertiary Care hospital | | |
Shukrath C, Kavitha R
Department of Pharmacology, Bangalore Medical College and Research Institute, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objective: To identify potential interactions among drugs prescribed to elderly in-patients in medicine department. Methods: This is a retrospective observational study conducted at Victoria hospital attached to Bangalore Medical College And Research Institute over a period of 3 months. All prescriptions of patients above 65years of age were analysed by using drug interaction software, LEXICOMP, inc. version: 2.8.0. for the presence of potential drug interactions. Results: A total of 300 subjects were included in the study. 58% of patients were male and the majority (75%) were in the age group of 65-75 years. The most common diagnosis which warranted admission to medicine wards was morbidities affecting respiratory system (28%) followed by central nervous system (20.5%). Type 2 diabetes mellitus and hypertension were most common co-morbidities. A total of 1450 drugs were prescribed. Average exposure per patient was 7.25. 44% had atleast 1 drug combination possibly leading to a drug-drug interaction (DDI), 9% of potential DDI were classified to be avoided according to LEXICOMP software. A total of 427 interactions were observed with an occurrence rate of 1.42 DDI per patient. Conclusion: Pharmacotherapy is complex in elderly patients. Doctors should know the most important DDIs of the drugs used to treat elderly as these patients are more vulnerable to adverse drug reactions.
Keywords: Adverse drug reactions, drug -drug interactions, elderly
| » Renal Oral | | |
| » RENO-1: Descriptive Analysis of Prescribing Patterns of Drugs in Chronic Kidney Disease Patients on Maintenance Hemodialysis in SMS Hospital Jaipur | | |
Chandel RK, Bhargava J1, Dadhich J1
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India,
E-mail: [email protected]
Objective: Prescribing patterns are studied to recommend necessary modifications towards the achievement of rational drug use. We studied prescribing patterns of drugs in chronic kidney disease patients on maintenance hemodialysis in SMS hospital Jaipur. Methodology: Prescriptions of 40 Patients on maintenance hemodialysis, age > 18 years of either sex were analyzed for co morbidities, drug use patterns, drug drug interactions, polypharmacy and adherence to therapy. Results: Prescription of 40 patients recruited over 2 months were analyzed .The median age was (IQR) 36 (25-49); 70% were male and 30% were female; Mean urea level (SD) was 117 (47) mg/dl, and creatinine level (SD) was 9.4 (2.34) mg/dl. The common comorbidities were anemia and hypertension. The median number of drugs per prescription were 7.5 (6.5-8) majority being cardiovascular drugs (28.7%) followed by hematopoetics (24.5%) and vitamins (20.9%). Median number of potential drug drug interactions (IQR) were 2 (2-3); Adherence level was high (90%) in majority of patients. Conclusion: The incidence of polypharmacy and adherence levels were acceptable. Although, there were significant drug drug interactions per prescription in the study population.
| » RENO-2: Evaluation of Nephroprotective Effect of costus pictus on Streptozocin Induced Diabetic Nephropathy in Rats | | |
Sanaye MM, Satyapal GG, Kulkarni YA1
Prin. K.M.Kundnani College of Pharmacy, 1Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: Diabetic nephropathy is major long term complication of diabetes mellitus . Costus Pictus (CP) is known for therapeutic benefits such as anti-diabetic, anti-inflammatory and anti-microbial activities hence attempts have been made in this study to investigate role of costus pictus in curbing the progression of diabetic nephropathy in rats. Methods: Dried leaves of CP were extracted in methanol (MECP). Quercetin and p-coumaric acid were identified and quantified in MECP using HPTLC. Diabetic nephropathy was induced in male wistar rats by single i.p. injection of freshly prepared STZ (50mg/kg). Animals with blood glucose level ≥250mg/dl were selected for the study and monitored every week for 28 days by estimating serum and urine biomarkers for diabetic nephropathy. Animals were treated with vehicle/standard/ test extract for 28 days after induction of diabetic nephropathy and were monitored weekly for levels of serum and urine biomarkers. At the end of experiment both the kidneys were excised. and used for histopatholgy and in vivo anti-oxidant assays. Results: Treatment of MECP alone and in combination with metformin and Enalapril (M+E+MECP) attenuated rise in levels of serum and urine biomarkers ,improved GFR along with glycemic control and showed protection against oxidative stress. Decreased expression of TGF and minimal histopathological changes confirmed nephroprotective effect of CP. Conclusion: Nephroprotective effect could be attributed to improved glycemic control by CP and antioxidant and anti-inflammatory effects of Quercetin and P-coumaric acid present in MECP.
Keywords: Costus pictus, diabetic nephropathy, P-coumaric acid, quercetin
| » RENO-3: A Study of Drug-drug Interactions in Patients of Chronic Kidney Disease at a Tertiary Care Hospital | | |
Latha K, Hema NG, Himamani S1
Departments of Pharmacology and 1Nephrology, Mysore Medical College and Research Institute, Mysore, Karnataka, India
E-mail: [email protected]
Objectives: The main objective of the study was to identify the potential Drug-Drug Interaction (DDI) among Chronic Kidney Disease (CKD) patients and to assess possible risk factors associated with these interactions. Materials and Methods: After obtaining approval from Institutional Ethics Committee, a prospective cross-sectional study was carried out for a period of three months from 1st June 2017 to 31st August 2017, at Nephrology department of a tertiary care hospital. Patients diagnosed with CKD by treating Nephrologist were included and their prescriptions analysed. The prescriptions were analysed for potential DDIs using MEDSCAPE multidrug interaction checker tool. The results were analysed using descriptive statistics, Student 't' test, ANOVA and Pearson correlation coefficient. Results: Among 120 prescriptions that were analysed, 79 patients had at least one interacting drug combination. Total number of potential DDI were 235. Majority of DDIs were moderate (63.5%) followed by minor (29.7%) according to severity assessment. Majority of interactions were pharmacodynamic (51%) in nature. Out of total prescribed drugs (618), cardiovascular class of drugs (46.8%) were most commonly involved drug class in DDIs. Considering individual drugs-aspirin, calcium salts, clonidine, furosemide and prazosin were the five most commonly involved drugs in potential DDIs. Most common drug combination involved in potential DDI were Calcium carbonate +amlodipine. Common risk factors associated with the potential DDI were elderly age group, co-morbid conditions and increased number of drugs. Conclusions: Drug therapy in CKD requires prescription of multiple drugs due to associated co-morbid conditions. This study provides an overview of the importance of routine monitoring of CKD patients & screening their prescriptions for potential DDIs to prevent possible DDIs and to reduce the incidence of preventable DDIs significantly. So that the patient receives utmost health benefit from the drug therapy.
| » Toxicity Oral | | |
| » TOXO-1: Effect of Oral Exposure to BISPHENOL a on Adult Male Rat Fertility | | |
Adki KM, Doshi T1, Naik SR2, Kumar MS, Vanage GR1
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, 1National Centre for Preclinical Reproductive and Genetic Toxicology, National Institute for Research in Reproductive Health, Mumbai, 2Department of Pharmacology, Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Maharashtra, India
E-mail: [email protected]
Background: Humans are ubiquitously exposed to Endocrine disrupters (EDs) like Bisphenol A (BPA) polymer which is used in the manufacture of polycarbonates. Objective: The main aim of this work was to study the effect of oral exposure of BPA on fertility of adult male rats and to delineate mechanism of action in androgen receptors at protein and gene level.Methods: The oral exposure of BPA of 20μg/kg body weight was given daily for 14 days to adult male rats. After 14 days of exposure we analysed hematology, differential leucocyte count (DLC), organ weight, histopathology, spermatogenesis, daily sperm production (DSP), staging of seminiferous tubules, copulation index, fertility index, sex ratio, pre and post implantation loss and expression of androgen receptors at protein by western blot and gene by reverse transcriptase polymerase chain reaction (RT-PCR). Results: The results revealed that the oral exposure of BPA (20μg/kg BW daily for 14 days) to adult male rats significantly reduced epididymal sperm count per caudal epididymis (83.75±4.5) ×106 as compared to control (98.8±4.20) ×106. This sperm count reduction was associated with the increase in post implantation loss of 6.25% compared to control 2.00% in normal cycling females which were copulated with BPA treated adult male rats. The testicular expression profile showed upregulation of androgen receptor at protein and gene level. Conclusion: The upregulation of androgen receptor might be associated with production of abnormal proteins which resulted in reduction of sperm count and increase in post implantation loss. The study concludes as oral exposure of adult male rats to BPA (20μg/kg BW daily for 14 days) acts as reproductive toxicant.
| » TOXO-2: Evaluation of Protein Mediated Oxidative Stress among Adolescent Inhalant users Seeking Treatment at a Tertiary Care Centre of North India | | |
Verma A, Jain R, Dhawan A, Lakshmy R
Department of Psychiatry, National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India
E-mail: [email protected]
Objective: Inhalant use is a serious medical problem as it can cause severe damage to various organs of human body. Literature suggests that intentional toluene inhalation causes a decrease in antioxidants and formation of oxidation products of proteins, lipids and DNA. The present study aimed to evaluate the effect of protein mediated oxidative stress among adolescent inhalant users seeking treatment at a tertiary care centre of India. Methods: The study included individuals exposed to toluene (Group I) and healthy individuals with no history of drug use (Group II). Five ml of blood and thirty ml of urine was collected from the subjects. Urinary Hippuric acid (UHA), Creatinine (CR) and Protein Carbonyls (PC) were measured using GC-NPD, Biochemistry autoanalyzer and ELISA multi-mode reader techniques respectively. Results: Total 134 males (toluene exposed, n=67 and unexposed, n=67) were included in the study. The mean age for Group I and Group II subjects was found to be 14.78(2.12) and 14.7(2.02) years respectively. Mean UHA/CR ratio in Group I and Group II was found to be 1.61(1.84) and 0.26(0.31) respectively. Serum analysis showed significant increase in Protein carbonyl contents in Group I subjects when compared with Group II [0.2 (0.1) per mg protein vs 0.03(0.01) per mg protein, U=0.00, p<0.001]. Conclusions: These findings support an association between protein oxidation and toluene inhalation. Future studies with larger sample size are needed to corroborate these findings. Supported by National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi and University Grants Commission, Government of India.
| » TOXO-3: Do Routine Laboratory Parameters Correlate with Alcohol Consumption? A Cross-Sectional Study from India | | |
Ghosh S, Jain R, Rao R, Mishra AK, Jhanjee S
Department of Psychiatry, National Drug Dependence Treatment Centre, All India Institute of Medical Science, New Delhi, India
E-mail: [email protected]
Objective: To assess the correlation of liver function tests and hemogram with alcohol use. Methods: Using cross-sectional study design, fifty alcohol dependent patients with last alcohol consumption within twelve hours were recruited after their consent. The subjective information included: socio-demographic details, alcohol use details and alcohol amount consumed in past three months (by beverage-specific quantity-frequency method). Five millilitre of venous blood was collected to estimate aspartate amino-transferase (AST), alanine amino-transferase (ALT), Gamma-Glutamyl Transferase (GGT), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH), Mean Corpuscular Haemoglobin Concentration (MCHC), RBC and platelet count. The values of these laboratory parameters were correlated with socio-demographic, clinical details, and quantity of alcohol consumed. Results: The mean age of the participants was 38.9 (SD:8.0) years. All participants used alcohol daily; country made liquor (CML) being the preferred beverage (66%, n=33). The mean quantity of alcohol consumed in past three months was 251.5 grams per day. The age of initiating morning drinking was significantly negatively correlated with alcohol amount consumed (p<0.05). AST, ALT, GGT, MCV, MCH, MCHC values did not correlate with duration of alcohol consumption, age of initiating daily drinking, morning drinking and quantity of alcohol consumed. Platelet count negatively correlated with last alcohol dose used (p<0.01). ROC analysis revealed 66.8% AUC (95%CI 0.50, 0.84, p=0.05) for CML level by MCH parameter. Conclusions: Most LFT and CBC parameters are not affected by alcohol use-related variables. There is a need to explore other laboratory markers that can predict alcohol use in resource-poor settings.
| » TOXO-4: Analysis of Mycotoxins Contamination in Animal Feed Samples by Thin Layer Chromatography | | |
Addison MP, Sarathchandra G, Vijayakaran K, Pothiappan P
Pharmacovigilance Laboratory for Animal Feed and Food Safety, DCAHS, TANUVAS, Chennai, Tamil Nadu, India
E-mail: [email protected]
Objective: Mycotoxin contamination in animal feeds is a major concern not only to the animal but also to the human being due to its residues in animal products. The present study was conducted to assess mycotoxin contamination (aflatoxin B1, B2, G1, G2, citrinin and ochratoxin A) in animal feeds. Methods: Extraction of mycotoxins from feed samples was done as per AOAC method using reference standards by Thin Layer Chromatography (TLC). Results: Out of 115 distiller's dried grains with soluble (DDGS) samples analyzed, the number of contaminated samples is highest with aflatoxin B1 (27.82 %, 10-40 ppb) followed by aflatoxin B2 (20.86 %, 5-20 ppb), citrinin (15.65%, 40-60 ppb), aflatoxin G1 and G2 (5%, 5 ppb each). While out of 50 compounded cattle feed samples analyzed, 33 samples (66%) were found to be contaminated with different mycotoxins in various concentrations: aflatoxin B1 (10-40 ppb), aflatoxin B2 (5-20 ppb), aflatoxin G1 and G2 (5 ppb each) and citrinin (40-60 ppb). Similarly, out of 26 poultry feed samples, 21 samples (80.76 %) were found to be positive for different mycotoxins of varied concentration; aflatoxin B1 (10-20 ppb), aflatoxin B2 (10 ppb), aflatoxin G1 and G2 (10 ppb each) and citrinin (40-60 ppb). Ochratoxin A was negative for all the 191 different feed samples analyzed. Conclusion: Contamination of feed samples with more than one mycotoxin is commonly encountered in the present study. Thus, regular screening of mycotoxins for every batch of animal feed reaching farmsteads needs to be done to ensure food safety.
| » TOXO-5: A Study on Serological and Hormonal Profile of Offspring Born to Chronic Cadmium Exposed Rats | | |
Shivakumar. P, Gopala Reddy A1, Ramya B2,3
1Department of Veterinary Pharmacology and Toxicology, College of Veterinary Science, 2Department of Veterinary Pathology, College of Veterinary Science, Korutla, 3PVNR TVU, Hyderabad, Telangana, India
Objectives: To study the serological and hormonal profile of offspring born to chronic cadmium exposed rats and to evaluate protective role of green tea if any. Methodology: Twenty four weaned Sprague dawley male rats were randomly divided into 4 groups of 12 rats in each(6 males+6 females). Group 1 served as Sham control, Group 2 was treated with CdCl2 @5mg/kg b.wt. per orally for 3 months, Group 3 was treated with Green tea (1.5%) and Group 4 with CdCl2 + green tea. In all the groups, females were mated at the end of three months with male rats belonging to respective groups/treatments and the treatment was continued till 17th day of gestation and the rats were allowed to normal delivery. The pups of F1 generation from all the groups were kept till weaning (post-natal day 21) and were subjected to sero biochemical (serum glucose, albumin, globulins, total proteins, total cholesterol and HDL cholesterol) and thyroid hormone profile were estimated. Results: There was increased serum glucose, total proteins, albumins, globulins, total cholesterol and HDL-cholesterol in group 2 as compared to control. The concentration of T3 in group 3 offspring was significantly (p<0.05) higher than the groups 1, 2 and 4. The concentration of T4 in group 2 offspring was significantly (p<0.05) lower than the groups 1 and 3. Conclusions: Treatment with green tea significantly ameliorated (p<0.05) toxic effects of CdCl2 by restoring biochemical and hormonal profile to normal. It is concluded that green tea exhibits protective property in CdCl2 induced toxicity.
| » Respiratory Oral | | |
| » RPHO-1: Comparative Study of Efficacy and Adverse Effect Profile of Theophylline and Etofylline Combination Verses Doxophylline in Patients with COPD | | |
Jiwane D
Department of Pharmacology, Gandhi Medical College, Bhopal, Madhya Pradesh, India
E-mail: [email protected]
Objective: COPD is one of the major public health problems worldwide. Theophylline has been used in the treatment of COPD for decades. Doxophylline a new theophylline congener has been claimed to have better safety profile. The study was undertaken to compare theophylline and doxophylline at doses recommended and commonly used in clinical practice. Materials and Methods: The study was conducted in patients of COPD in TB chest department of a medical college hospital. It was randomized and prospective study. A total of 120 patients were divided in two groups. Group I was administered theophylline 69 mg + etofylline 231mg (Deriphylline Retard 300 mg) once a day and group II was administered doxofylline 400 mg twice a day orally. Spirometric variables and adverse effects were recorded on day 0, 7 and 21 of therapy. Data were compared and analysed using SPSS version 16. Results: Results of the study showed that there was no statistically significant difference with respect to spirometric variables in the two groups and there was no significant difference in two groups with respect to side effects (p>0.05). Conclusion: It is concluded that doxophylline has no advantage over theophylline in terms of either efficacy or safety on the doses commonly used in current clinical practice.
| » RPHO-2: A Study of Adverse Effects of Second Line Antitubercular Drugs in Mdr Tuberculosis Patients | | |
Bharadwaja P, Virupaksha HM, Parashivamurthy BM
E-mail: [email protected]
Aim: The aim of this study was to assess risk factors related to second line anti-tubercular drugs related ADRs and to study causality and severity assessment of reported ADRs. Methods: A prospective observational study was conducted in PKTB hospital for a period of 1 year with focus on 65 patients who were admitted for MDR-TB in PKTB hospital. ADRs were assessed with Naranjo algorithm, Hartwigs & Seigel Scale, data recorded and relavant statistical analysis was done. Results: The study showed out of the 65 patients 40(61.6%) had experienced ADRs. Majority of adverse drug reactions occurred in patients aged 25-45 years (62.5%). Most of the ADRs were related to Gastrointestinal system (55%) and Dermatological (22.5%) and CNS and psychiatric combined accounting to (12.5%). Naranjo causality assessment showed 65% were possible, 25% were probable and 10% were definitive ADRs. Of the total adverse drug reactions 77.5% were mild 17.5% were moderate and 5% were severe in intensity. Conclusion: Adverse drug reactions among the patients with second line anti-tubercular drugs is a critical public health issue for anti-tubercular therapy adherence. Therefore, continuous monitoring is required to prevent severe ADRs and to improve patient compliance.
Keywords: Adverse drug reactions, multi drug resistant tuberculosis, second line anti-tubercular drugs
| » RPHO-3: Assessment of Patient Satisfaction and Preferences with the use of Budesonide/Formoterol Fixed Dose Combination by Pressurised Metered Dose Inhalers and Dry Powder Inhalers in Patients of Moderate Persistent Asthma | | |
Gupta MC, Chaudhry D1, Khanna J
Departments of Pharmacology and 1Pulmonary and Critical Care Medicine, Pandit B. D. Sharma, PGIMS, University of Health Sciences, Rohtak, Haryana, India
Objective: Combination inhalers like pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) that contain a corticosteroid and a long acting β2 agonist (LABA) (e.g. budesonide/formoterol) are widely used in asthma treatment. This study assessed the patient satisfaction and preference of budesonide/formoterol fixed dose combination by pMDI and DPI in patients of moderate persistent asthma. Methods: This was a 6 week prospective, randomized, open label, comparative, parallel group clinical study. All patients had a forced expiratory volume in 1 second (FEV1) of 60–80% predicted normal. The patients were assessed for satisfaction in group I (pMDIs) and group II (DPIs) using patient evaluation questionnaire and the 15 item patient satisfaction and preference questionnaire (PASAPQ) at the end of 6 week. Results: In patient evaluation questionnaire statistical analysis of the mean attribute ratings showed that both the devices were easy to use by the patients. The overall liking for the two devices was found to be statistically insignificant. In PASAPQ, the patients in group II were very satisfied with the treatment in terms of following parameters- overall feeling of inhaling, amount of medication left, working of device, ease of inhaling a dose, the speed with which medication comes out, instructions for use, size and durability of inhaler, ease of cleaning and holding the inhaler. Conclusion: The overall liking for both devices was similar for both devices in terms of sensory perceptions. The satisfaction levels were higher for patients using dry powder inhalers than patients on pressurized metered dose inhalers.
| » RPHO-4: Cohort Event Monitoring of Bedaquiline in Patients with Drug Resistant Tuberculosis | | |
Barvaliya SB, Desai MK1, Panchal JR1, Solanki RN2
Departments of 1Pharmacology and 2Pulmonary Medicine, B. J. Medical College, Ahmedabad, Gujarat, India
[email protected]
Objective: To evaluate safety and efficacy of bedaquiline based regimen for drug resistant tuberculosis (DR-TB) patients. Materials and Methods: A prospective, observational study was conducted on patients prescribed bedaquiline (400mg/daily for initial 14 days followed by 200mg on alternate day) along with other second line anti-tubercular agents as per drug sensitivity results. Demographic details, clinical symptoms, sputum / culture and laboratory investigations, drug treatment details were recorded at baseline and each follow up for six months. ECG monitoring was done at baseline and daily for initial 14 days followed by weekly for two weeks and then monthly for five months. Results: Out of 103 patients, majority (80,77%) received category I and IV previously and were resistant to isoniazid and rifampicin (103,100%), levofloxacin (85,83%) and moxifloxacin (76,74%). A significant increase in mean body weight (5.39 kg) was observed in at the end of six months treatment (p<0.0001). Out of 103 patients, 60 (58%) were converted into sputum negative with mean sputum culture conversion time 36.7±3.74 days. A significant increase in mean QTc interval (16.1ms) was observed at third week of bedaquiline treatment (p<0.0001), albeit, it remained within acceptable limits (≤450ms). A total of 64 adverse drug reactions were reported. Most common was vomiting and abdominal discomfort (13) followed by difficulty in hearing and giddiness (6). Conclusion: Bedaquiline based regimen was well tolerated and none of the patients were withdrawn due to safety reasons. In addition, a significant clinical and bacteriological improvement was observed.
| » RPHO-5: The Study of Adverse Drug Reactions in Indoor Patients of Tuberculosis Taking Standardized Antitubercular Therapy (DOTS and PMDT) in a Tertiary Care Hospital at Surat | | |
Naik PP, Panwar AS, Vadgama PK1, Pandey AS2
Departments of Pharmacology and 2Respiratory Medicine, SMIMER Medical College, VNSGU, 1Department of Respiratory Medicine, Government Medical College, VNSGU, ↱ Surat, Gujarat, India
E-mail: [email protected]
Objectives: To assess the adverse drug reactions (ADRs) caused by anti tubercular therapy under RNTCP (DOTS & PMDT) in indoor patients on basis of causality and severity scales. Methods: The Observational, prospective study was carried out for one year period. The causality was determined by WHO UMC scale and severity was determined by Modified Hartwig & Siegel scale. Chi square(X2) test was applied for association between variables. Results: Among 255 tuberculosis patients, 85 (33.3%) patients developed ADRs. Occurrence of ADRs was more among females (46.6%). Majority of ADRs developed in less than 30 days of therapy (49.4%). The commonly involved systems are gastrointestinal (40.6%) followed by haematological (17.9%). The most common ADRs observed was nausea and vomiting (21.7%) followed by hypokalemia (15.1%). High percentage of ADRs causing drugs were isoniazid (30.6%) followed by rifampicin (26.1%). Causality assessment showed 60.4% ADRs were possible, 37.7% ADRs were probable and 1.9% ADRs was certain. Severity assessment scale showed 81.1% of moderate, 12.3% of mild and 6.6% of severe grading. Occurrence of ADRs was more among Programmatic Management of Drug resistant Tuberculosis (PMDT) therapy (60%) in comparison to Directly Observed Treatment Short-course (DOTS) therapy (31.06%) [p value = 0.0084 (significant p value < 0.05)]. Conclusion: Anti tubercular treatment is safer but early detection, management and pharmacovigilance reporting of ADRs is required to prevent it at initial stage and helps to decrease default rate.
| » RPHO-6: Evaluation of Efficacy and Safety of Inhaled Tiotropium and Budesonide with Inhaled Formoterol and Budesonide in Patients Suffering from Severe COPD | | |
Jagdhani RS, Dudhgaonkar Sujata, Bhadke BB, Bende MM, Bachewar NP
Department of Pharmacology, Shri Vasantrao Naik Government Medical College and Hospital, Yavatmal, Maharashtra, India
E-mail: [email protected]
Background/Objective: Severe COPD cases (post-bronchodilator FEV1<50% predicted) are at high risk of exacerbation. Inhalational corticosteroids (ICS) are recommended along with long acting bronchodilators, either Tiotropium (LAMA) or Formoterol (LABA). Very few studies have combined Tiotropium (LAMA) with Budesonide (ICS) and compared it with LABA+ICS combination in severe COPD. Methods: Study was prospective, randomized, open labelled, two parallel group, comparative controlled clinical trial. 80 patients were randomized into 2 groups. Group A received Tiotropium 18mcg OD and Budesonide 400mcg BD, while group B received Formoterol 6mcg + Budesonide 400mcg BD for 12 weeks. Efficacy was evaluated by post-bronchodilator FEV1, 6 min walk distance (6MWD) and use of rescue medication, while safety by the incidence of adverse events. Results: Baseline characteristics of both the groups were similar. Baseline post-bronchodilator FEV1 (% predicted) was 38.70 ± 0.982 and 40.90 ± 0.9007 in group A and B respectively (95% CI -4.857 to 0.4571). At end of 12 weeks it was 48.95 ± 1.517 in group A and 52.13 ± 1.217 in group B (95% CI -7.054 to 0.7042). 6MWD (in metres) was 181.2 ± 8.204 for group A and 173.4 ± 8.418 for group B (95%CI -15.59 to 31.29) at baseline. After 12 weeks it was 219.4 ± 9.546 for group A and 207.3 ± 9.466 for group B (95% CI -14.76 to 38.86). Incidence of adverse events was similar. Conclusion: The treatment with Tiotropium 18mcg and Budesonide 400mcg was similar in efficacy and safety when compared with Formoterol 6mcg + Budesonide 400mcg.
| » RPHO-7: A Study on Pattern of Prescription among Asthma Patients in a Tertiary Care Hospital of South India | | |
Priyadarshini BG, Ravikumar P1
Departments of Pharmacology and 1Pulmonology, Sridevi Institute of Medical Sciences, Tumakuru, Karnataka, India
E-mail: [email protected]
Objectives: Present study aims to find out pattern of prescription among adult asthma patients in a tertiary care hospital of south India. Methods: Asthma patients attending out-patient department were selected for the study after getting ethical clearance from Institutional Ethics Committee. After obtaining informed consent patients were given predesigned questionnaires. Descriptive analysis method was applied for statistical analysis. Results: 160 adult asthma patients who visited outpatient department of pulmonary medicine during September to November 2017 were analyzed. We noted Mild asthma in 35% and Moderate asthma in 65% of cases. Highest prevalence was seen in 20-30 yrs (48%) and lowest in 50-60yrs (10%) age group. We noted 35 different drugs prescribed for study patients. Each patient was prescribed 2-5 drugs (average 2.1). Inhalational route of drugs were prescribed in 64% and 36% by oral route. Highest number of patients received inhaled corticosteroids (82%) followed by long acting β2 Agonists (76%) among which formoterol prescribed highest (72%) compared to salmeterol (28%). Among oral drugs, Leukotriene modifiers were prescribed highest (64%) followed by Levo-cetrizine (46%), corticosteroids (15%), Methylxanthines (14%) and inhaled anticholinergics (5%). Other drugs like antibiotics (24%), Paracetomol (5%) and cough syrups (12%) were also co prescribed. Conclusion: Among inhaled drugs corticosteroids were most commonly prescribed drugs (82%) followed by LABA (72%) which included formoterol (72%) and salmeterol (28%). Among oral drugs Leukotriene modifiers (64%) were prescribed highest. Study also revealed fair knowledge regarding use of various Inhalational devices among patients.
Keywords: Asthma control action plan, asthma, Long acting beta-2 agonists, meter dose inhalers, spacers
| » Other Oral | | |
| » OTHO-1: A Prospective Observational Study of Prescription Pattern of Topical Steroids in Dermatology OPD, BRIMS, Bidar | | |
Amrutha T, Gumma KM
Department of Pharmacology, RGUHS, BRIMS, Bidar, Karnataka, India
Objective: To assess the prescription pattern of topical corticosteroids in patients attending dermatology OPD, BRIMS, Bidar. Materials and Methods: It was a prospective observational study. The prescriptions of patient attending the dermatology OPD were screened for the usage of the corticosteroids. The demographic data, chief complaints, diagnosis and the details of the drugs was collected and analyzed. Results: Out of 415 patients screened, 13.97% were prescribed corticosteroids. Corticosteroids prescribed by generic name were 26.01% and brand name was 82.05%. Corticosteroids alone prescribed in 42.02% and along with antihistaminics/antibiotics/emollients in 66.04%. Topical corticosteroids were prescribed in 86.02% patients and 22.04% by systemic route. Moderately potent steroids prescribed in 80.42% followed by potent (15.07%) and very potent steroids (12.56%). No fixed dose combination drugs were prescribed. Conclusion: The corticosteroids prescribed by brand names (82.05%) were more than generic names (26.01%), information about the strength of the steroid not mentioned and usage of emollients was less. This indicates the need for continuous medical education for the clinicians.
| » OTHO-2: Development and Implementation of Pharmacology Museum as a Teaching-learning Tool | | |
Parmar UI, Tripathi RK, Gajbhiye SV, Rege NN
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To evaluate the perception of II year medical undergraduates on pharmacology museum as teaching learning tool. Methods: After obtaining voluntary written consent, II MBBS students were enrolled in this study. An additional museum was created for easy visibility and access. The display cards with drugs pertaining to two finalized systems were displayed. The teaching learning activity was planned for 2 phases; in phase 1 the students were mandatorily instructed to visit the museum and see the various dosage forms for a given period of time. A pre-test and post-test, consisting of 21 validated MCQs was conducted. Phase 2 comprised of voluntary visits. Students were given opportunity to clear their doubts. At the end of phase 2 the perception of the student for the museum as a teaching-learning tool was recorded. Results: The student's perception questionnaire was analyzed using descriptive statistics. Pre- and post-test scores were compared using paired student 't' test. Out of 173 students, 85 felt that display information was adequate and 77 opined that information brought clarity. Students (97) felt that visualizing the drugs helped them to remember the various dosage forms better, museum inspired them to read about the dosage forms (90), encouraged self learning (107) and expect to score better in exams (88). Conclusions: Students perceived that museum improved their knowledge regarding dosage forms but they found it to be non-appealing which has posed a bigger challenge to the teaching faculty to make museum interesting and resourceful.
| » OTHO-3: Effect of Leptin on Spatial Learning and Memory and Blood Glucose Level in Streptozotocin Induced Diabetes Mellitus in Male Wistar Albino Rats | | |
Joshi A1,2, Patel C1,2
1Department of Pharmacology, Government Medical College, 2Veer Narmad South Gujarat University, Surat, Gujarat, India
E-mail: [email protected]
Objectives: This study was undertaken to study the effect of administration of leptin on spatial learning and memory and blood glucose levels in diabetic rats. Materials and Methods: Rats were divided into three groups. Each group comprised of 5 animals. First group was the control group. Diabetes was induced in group 2 and 3 by streptozotocin(STZ) injection intraperitoneally (i.p.). Group 2 received saline while group 3 received leptin(0.1 mg/kg) subcutaneously (s.c) for 10 days from 4th day of STZ administration. Behavioural assessment was done using T maze after 21 days of the last injection of leptin. Blood glucose levels were also analysed. Results: Streptozotocin administration to the group 2 and group 3 rats increased blood glucose levels when compared to group 1. Leptin administration decreased blood glucose levels in the group 3( 236±9.06) when compared to group 2 rats(284.8 ± 6.61) (p <0.05). Spontaneous alternation rates also were increase in group 3 when compared to group 2( p <0.01). Time taken to reach the correct arm decreased in group3 when compared to group 2 (p<0.05). Time spent immobile in the task was also decreased in group 3 when compared to group 2 ( p <0.01). Speed of rats increased in group 3 when compared to group 2 but no statistically significant difference was observed. Conclusion: Our study suggests that leptin can improve learning and memory while also producing a slight reduction in the blood glucose levels in diabetic rats.
| » OTHO-4: Comparison between Anti-diabetic Effect of Ethanolic Extract of Hibiscus Rosasinensis Leaves and Flowers in Diabetic Rats | | |
Gala M, Pathak S
Department of Pharmacology, DMIMS (DU), Jawaharlal Nehru Medical College, Wardha, Maharashtra, India
E-mail: [email protected]
Objective: The main objective of the study was to compare the effect of respective extracts of hibiscus rosa sinensis flower and leaf on blood glucose level in comparison with a standard drug of choice. Methods: Diabetes was induced in the experimental animal with a chemical Alloxan. The experimental animals selected were wistar rats of male gender. They were divided in to 4 groups according to the line of treatment. Blood sugar levels were monitored at regular intervals for a total period of 21 days. Results: From the data collected over 21 days, it was clearly visible that the extract of flower component of the hibiscus flower proved to be more effective in decreasing the blood sugar then the leaves extract component. Neither of the extracts produced hypoglycemia which was noticed in the animals treated with the standard drug of choice. Conclusion: Despite the extracts decreasing the blood sugar levels safely without any serious adverse effect, to consolidate the claim as a better alternative to the standard drug of choice, further studies involving bigger sample size and human clinical trials are required.
| » OTHO-5: Pattern of Antimicrobial Utilization for Surgical Prophylaxis to Prevent Surgical Site Infection in Tertiary Care Teaching Hospital | | |
Dudhgaonkar S, Bende MM, Jagdhani RS, Siddhawar NB
Department of Pharmacology, SVNGMC, Civil Lines, Yavatmal, Maharashtra, India
E-mail: [email protected]
Background: Surgical site infections (SSIs) are the second most common nosocomial infections and have adverse impact on patient. Despite proved effectiveness of surgical antimicrobial prophylaxis in reducing morbidity and mortality use is often inappropriate. However, this inappropriate use of antimicrobial agents (AMAs) leads to emergence of resistance. The objective of this study is to evaluate the pattern of surgical antimicrobial prophylaxis in our hospital to decrease SSIs and to suggest corrective measures. Materials and Methods: 201 medical records of general surgery department were analysed retrospectively for five parameters of rational surgical antimicrobial prophylaxis like (i) selection (ii) timing of pre-operative dose, (iii) intra-operative dose, (iv) duration of post-operative prophylaxis and (v) unnecessary use of antimicrobial agents (AMA) were evaluated using ASHP (American Society of Health-System Pharmacists) guidelines. Results: Total 201 patients were prescribed AMA for surgical prophylaxis. The most frequent use of AMA was third generation cephalosporin and metronidazole. With regards to pre-operative dose 33.83% patients received AMAs 12 hours before surgery while no patient received intra-operative AMA. The duration of the postoperative prophylaxis extended more than 48 hours in 89.55% cases during their hospital stay. 11.94% and 35.32% cases were given unnecessary AMA in pre-operative and post-operative period respectively. 89.55% cases received AMA for long prophylaxis. Conclusion: Current study revealed there is inappropriate use of AMA to prevent SSIs such as mistake in selection of AMA, excessive dosing and prolonged prophylactic use of AMA.
Keywords: Antimicrobial prophylaxis, retrospective, surgical site infection
| » OTHO-6: To Assess the Knowledge Awareness and Practice about Pharmacovigilance | | |
Saini P, Patel P
Index Medical College Hospital and Research Center, Indore, Madhya Pradesh, India
E-mail: [email protected]
Objective: To assess the perception and attitude of pharmacovigilance program among Junior doctor. Methods: The study was conducted in the Department of Pharmacology. In this study, junior doctors (Intern and P.G student) will be included. All the students will be given a form containing total 25 questions on different aspect by using KAP questionnaire. Results: Among 240 questionnaires distributed, 220 questionnaires were filled properly. 92.27% junior doctor correctly knows the pharmacovigilance. 65.45% junior doctor knows what adverse drug reaction exactly means. 169 (76.81%) junior doctor knows which regulatory body is responsible for monitoring ADRs in India.215 (97.72%) believe reporting of ADR is necessary.. 167(75.90%) junior doctor have attitude to discuss regarding ADRs before prescribing medicines. 117(53.18%) aware that ADR can be reported through mobile app, but did not know its name. 63.18% junior doctors have Opinion that ADR monitoring center should be in every hospital . 51.36% belief that, there should be training in every 6 months. 41 % says that notification of ADR is important to develop safety measure for the use of a particular drug. Conclusion- Majority of junior doctors are well acquainted with pharmacovigilance ADRs & its reporting.More than 50% believe need for improvement,better & easy reporting of ADRs should be implemented in hospitals.Moreover,few had knowledge that ADR could be reported on mobile app can prove to be an essential role in ADRs monitoring.
| » OTHO-7: Incidence of Animal Bite and Anti-rabies Vaccine Utilization in an Anti-rabies Clinic in Northeast India | | |
Marak MD, Wahlang JB1, Brahma DK
Pasteur Institute, 1Department of Pharmacology, NEIGRIHMS, Shillong, Meghalaya, India
E-mail: [email protected]
Objective: To assess the incidence of animal bite including dog bite and utilization of anti-rabies vaccine between January 2011 and December 2015. Methods: Reported cases of animal bite including dog bite archives were collected and analyzed in the outpatient department of anti-rabies virus (ARV) clinic of the Pasteur Institute, Shillong, Meghalaya, India. Results: A total of 22571 cases of all age were reported, out of which 19513 were dog bite and 3058 were other animal bite cases. The dogs involved in bite cases were suspected rabid dogs, pet dogs and stray dogs, and the other animals involved are mostly cats, pigs and monkeys. While the overall male and female ratio of all bite cases was 1: 0.704, the ratio in dog bite and other animal bite categories were 1.5: 1 and 0.6: 1 respectively. The overall children to-adult ratio is 0.90:1. The college/school going students are most victims of dog bite amounting to 57.05% followed by labourer category with 22.24%. Categorization of bite cases as per WHO guidelines showed 5.83%, 14.99% and 79.17% of cat-I, cat-II and cat-III respectively. A total of 32075 doses of 5 days regime and 40332 doses of 3 days regime vaccines administered to 28.42% and 59.56% cases respectively. The treatment drop out cases amounts to 5.81% and 20 hydrophobia cases registered in this period. Conclusion: Dog bite cases are very common in this region and the incidence is increasing every year. Adequate amounts of supply and stocking of anti-rabies vaccine is important in this region.
| » OTHO-8: Evaluation of Prescribing Pattern in Medicine Ward, Before and After Prescriber Sensitization, at a Tertiary Care Teaching Hospital in Maharashtra | | |
Choudhari SR, Bachewar NP, Dudhgaonkar SS
Department of Pharmacology, Shri Vasantrao Naik Government Medical College, Yavatmal, Maharashtra, India
E-mail: [email protected]
Objectives: Rational prescribing is an essential skill for every prescriber. Many times it seems a difficult task for various reasons. Such irrational practices lead to increase in mortality, morbidity and financial burden on the patient. Regular prescription audit, feedback and prescriber's sensitization would help to improve prescribing habits. Hence, we aimed our study to evaluate appropriateness of prescription pattern according to WHO drug prescribing indicators, complementary indicators, Neville's criteria of prescription errors and look for impact of sensitization on prescribing habits. Methods: A longitudinal study, conducted in medical record section and medicine department of tertiary care teaching hospital of Maharashtra during the period of 18 months. Total 400 randomly selected prescriptions from Medicine inpatient wards were scrutinized retrospectively in each of stage 1 and 3. In stage 2, sensitization through power point presentations and personal discussion was done. Results: Average number of drugs per prescription was significantly (p=0.028) reduced to 4.93 in stage 3 from 5.20 of stage 1 after sensitization. Use of generic name was significantly (p<0.0001) increased to 48.17% and percentage of drugs prescribed from NLEM was increased to 77.05% after sensitization. Prescriptions with legible handwriting and proper dose, duration & frequency were significantly (p<0.0001) increased to 73.25% and 93.5% respectively in stage 3 as compared to stage 1. Also, total number of prescription errors was reduced to 28.25% in stage 3 after prescriber's sensitization. Conclusion: The present study showed, prescribing habits can be improved by regular prescription audits, proper feedback and periodic sensitization of prescriber.
| » OTHO-9: Knowledge, Attitude, and Practices of Pharmacovigilance and Adverse Drug Reaction Reporting among Medical Students in S.M.S. Medical College, Jaipur | | |
Rani M, Sharma L
Sawai Man Singh Medical College and Hospital, Jaipur Rajasthan, India
E-mail: [email protected]
Objective: The present cross-sectional questionnaire study was conducted with an aim of assessing the knowledge, attitude, and practice (KAP) related to pharmacovigilance among medical students in S.M.S. Medical College, Jaipur. Methods: A total of 250 medical students participated in the study. A self-administered prevalidated, semistructured questionnaire 14-item questionnaire was used to understand student's familiarity with regard to pharmacovigilance. Results: Mean score of completeness of the questionnaire was 19.04 out of 20.During the study it was found that most of the students (80%) were aware of the definition of pharmacovigilance and 85% participants were of the view that ADRs should be reported by only doctors. Only 60% participants know about the location of international ADR monitoring centre and 90% participants know about institutional ADR centre. Whereas 74% opined that only serious ADR with any medicine should be reported and only 20% participants felt that ADR reporting is a professional obligation for doctors. 95% participants were of the view that pharmacovigilance should be taught in detail to healthcare professionals. Out of 81% of those seen ADR, only 20% of them reported it.Conclusion: We conclude that to improve the adverse drug reaction reporting in India, pharmacovigilance should be taught in details during undergraduate. During internship, students should be motivated to fill the case report form and participate in pharmacovigilance program and for students should be awarded to motivate them. It has been advised that medical students should be trained properly on ADR reporting to improve the pharmacovigilance program of the country
| » OTHO-10: Evaluation of Efficacy of Two First Line Antiretroviral Drug Regimens used in HIV Infected Adult Patients Attending the Antiretroviral Therapy Centre in a Tertiary Care Hospital | | |
Deori K, Chaliha M, Pegu UR
Department of Pharmacology, Antiretroviral Therapy Centre, Jorhat Medical College and Hospital, Srimanta Sankaradeva University of Health Sciences, Guwahati, Assam, India
E-mail: [email protected]
Objective: To compare the effectiveness of two first-line antiretroviral regimens used for the treatment of HIV-naïve adult patients attending ART centre at JMCH. Methods: A prospective observational study was carried out in JMCH for a period of 6 months (1st May to 30th Nov 2017). After getting Institutional ethics committee permission, 42 newly diagnosed HIV/AIDS adult patients of either sex were included in the study. Patients were divided in Group A receiving Zidovudine 300mg + Lamivudine 150mg + nevirapine 200mg (ZLN) and Group B receiving Tenofovir 300mg + Lamivudine 300mg + Efavirenz 600mg (TLE). Different parameters i.e. CD4+ cell count, haemoglobin (Hb%) and mean weight of the patients recorded at the beginning of the study as baseline and after 6 months of receiving ART. Data obtained were computed and analysed statistically using excel and SPSS16. Results: There was significant increase in the CD4 cell count in both the groups after 6 months of ART (p<0.05) but no significant difference was observed between Group A (126±8 cells/μL) and Group B (133±8 cells/μL). Also there was increase in the mean weight of the patients in both the groups after 6 months of ART (2kg and 6kg respectively). However there was significant decrease in the Hb% in Group A (73.68g%) compared to Group B (26.08g%) after 6 months of ART. Conclusion: Both the ZLN and TLE regimen are equally effective in increasing the CD4 cell count and mean weight after 6 months of ART treatment but ZLN regimen has more haematopoetic side effects.
| » OTHO-11: Antibiotic Overuse and Resistance: An Awareness Study | | |
Desai SR, Undale VR
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, Maharashtra, India
E-mail: [email protected]
Objective: Antibiotics, first-line treatment for microbes-induced illnesses, indiscriminate use of which has led to increased resistance problems. Pharmacy students who are directly involved in drug distribution system should have sound knowledge about antibiotics and their resistance. The primary objective of this study was to assess awareness on antibiotics and its resistance in pharma students. Methods: Study was carried out in November 2017. Questionnaire was prepared, validated and filled by students. Knowledge and attitude towards antibiotic use and their resistance was studied. Inclusion criteria: First year B. Pharm (group A) and M. Pharm (group B) students. Exclusion criteria: Other class groups Data was collected, analysed for statistical significance using GraphPad Prism-7. Results: Study reveals that knowledge of antibiotics and its resistance is better in group B compared to group A. However, results were not satisfactory. Antibiotic side effectswere known by 36% group A and 68%group B students.28% students from each group were aware about antibiotic resistance. Among that, 12% and 64% students from groups A and B agreed that antibiotic resistance is global problem, 44% and 68% students fromgroup A and B know that irrationaluse of antibiotics lead to resistance. The results were statistically non significant. Conclusions: Pharma students, who may play an important role in treatment of microbial illnesses, do not have accurate knowledge about antibiotic use and its resistance. Appropriate knowledge can help them preventing emergence of resistance. Hence, special sessions on antibiotics should be conducted in pharmacolleges for lowering resistancerisk.
| » OTHO-12: Anaemia Awareness Study | | |
Undale VR, Desai SR
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, Maharashtra, India
E-mail: [email protected]
Objective: The young population are seeming to be ignorant about knowledge pertaining to health aspects and importance of nutrition for healthy life. Haemoglobin is one of the key factors contributing towards healthy living. Thus, awareness is one major step for healthy life. The objective of this study is to assess awareness regarding anaemia amongst young pharma students.Methods: This survey study was carried out in November 2017. A questionnaire was prepared, validated and filled by the students. Along with demographic details, data pertaining to the knowledge and attitude towards anaemia was compiled. Inclusion criteria: First year B. Pharm (group A) and M. Pharm (group B) students. Exclusion criteria: Other class groups
Data was collected and analysed for statistical significance using GraphPad Prism 7. Results: Study reveals thatthe basic knowledge of anaemia is similar in both the groups, but it was not satisfactory. However, it was observed that group A students had better knowledge regarding causes (32%), prevention (96%), types(20%) and normal haemoglobin levels in humans; while in group B 28% knew causes, 80% had knowledge about the prevention and 0% students knew 5-6 types of anaemia. Whereas, group B students (64%) were better than group A (40%) students about treatment aspect. The results were statistically non significant, except for types of anaemia (p= 0.0377). Conclusions: With passage of time, the students are disremembering the topic taught during their academic sessions. Hence, a continuous assessment and education on nutritional problems, such as anaemia, is required for healthy India.
| » OTHO-13: Hepatoprotective Activity of Aqueous Extract of Tagetes patula Flowers Against Paracetamol Induced Liver Damage in Albino Rats | | |
Bhattacharjee A, Nameirakpam MD
Department of Pharmacology, Regional Institute of Medical Sciences, Imphal, Manipur, India
E-mail: [email protected]
Objective: In the present study hepatoprotective activity of aqueous extracts of Tagetes patula flowers were tested against Paracetamol induced hepatotoxicity in albino rats. Methods: Albino rats were divided into five groups of 6 animals each. Group 1(normal control) received Normal Saline orally. Animals of group 2 to 5 received Paracetamol 2gm/kg p.o on 7th day. Group 2(toxic control) animals received Paracetamol 2gm/kg p.o without any drug treatment. Group 3(standard control) received the standard drug, silymarin 25mg/kg p.o daily whereas Group 4 and 5(test1 & test2) received varying dose of aqueous extracts of Tagetes patula flowers (200mg/kg and 400mg/kg) for 7 days. Liver marker enzymes (ALT, ALP,AST) and Serum total Protein were evaluated and histopathological examination of liver was done for all groups on day 8. Results: Oral administration Paracetamol (2gm/kg) increased the serum alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase(ALP) and decreased the serum total protein. Pre-treatment with aqueous extract of Tagetes patula flowers and standard drug silymarin significantly reversed the histopathological changes and serum marker levels (P<0.05) compared to toxic control group. Conclusion: This study suggested hepatoprotective effect of aqueous extract of Tagetes patula flowers against Paracetamol induced hepatotoxicity.
| » OTHO-14: Cost effective Analysis of Tablet Nitrofurantoin vs Injection Ceftriaxone as an Empirical Therapy for Uti Inpatients at a Tertiary Health Center | | |
Yadav NS, Pathak SS
Department of Pharmacology, Datta Meghe Institute of Medical Sciences, Jawaharlal Medical College, Wardha, Maharashtra, India
E-mail: [email protected]
Objective: To study the cost effective analysis of Tablet nitrofurantoin vs injection ceftriaxone in adult uti inpatients at a tertiary health center, Methods: A prospective study was performed on 50 cases of urinary tract infection in adult population at ACHARYA VINOBA BHAVE RURAL HOSPITAL (sawangi). A cost effective analysis(CEA) was done by calculating the cost , number of days of admission in wards(until no symptoms were present) to find out the most cost effective antibiotic used for patients in uti in the medicine/surgery/obstetrics-gynaecology ward. Results: Out of the 50 patients admitted for UTI,25 patients with similar symptoms getting treated with tab nitrofurantoin were compared to 25 patients with similar symptoms getting treated with inj ceftriaxone. The average number of days for which patients stayed in hospital was more for the group treated with inj ceftriaxone. Tab Nitrofurantoin was found to be more cost effective as compared to inj ceftriaxone. Conclusion: In the current study Tab Nitrofurantoin was found more cost effective to inj ceftriaxone as an empirical treatment in adult inpatients suffering from UTI at a tertiary healthcare center.
| » OTHO-15: Evaluation of Attitude, Perception and Preferences in Pharmacology Teaching Techniques: A Questionnaire Based Cross Sectional Study | | |
Singh A, Srivastava B, Bhardwaj R, Gaur S, Basumatory B
Department of Pharmacology, Government Medical College, Haldwani, Uttarakhand, India
E-mail: [email protected]
Objective: This study evaluates medical student's attitude and preferences in the methods of teaching in pharmacology to make the process of teaching more beneficial for the students. Methods: A questionnaire based cross sectional study was conducted on 178 MBBS students and analysed. Results: 28% students feel that pharmacology is an important subject of their curriculum, 16% find it interesting. 30% students find lectures as most useful type of teaching method, 21% students find tutorial as most useful. 46% students find PowerPoint method useful and interactive teaching technique and 42% find calk and board method more beneficial. 22% students find CNS as most interesting unit. 39% think that ANS is toughest unit. 33% use repeated revision method to memorize drugs names, 31% use pneumonic. 42% prefer semester exams as best method of evaluation.23% use text book and class notes both to prepare for exams.46% students are able to retain most of the lessons in class.41% are able to recollect more than half of the topics taught in class. 78% think that are morning time is best for the lectures.72% feel that combination of English and Hindi both is best method of communication during teaching.42% students feel free to ask questions in class although 41 % feel shy. 76% students are satisfied with their exam results.90% students find computer simulation exercises very helpful in understanding of the subject.27% think that frequent tests and quiz will help them in learning of pharmacology. Conclusion: PowerPoint method should be used most frequently for teaching. Students should be encouraged to ask more questions and to actively participate in different academic activities. Number of tests can be increased. Innovative methods should be used to make the subject more interesting for the students.
Keywords: Computer simulation, pharmacology, power point, questionnaire
| » OTHO-16: Usage of Smart Phones for Learning amongst Medical Students in Rajasthan: A Cross-Sectional Study | | |
Yadav D, Sharma S1, Sharma L2, Mathur SK
Department of Pharmacology, J.L.N Medical College, Ajmer, 1Jhalawar Medical College, Jhalawar, 2Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India
E-mail: [email protected]
Objective: The present study was conducted to assess the utilization of mobile phones by medical students as an educational tool and its perceived advantages and barriers. Methods: It was an observational cross-sectional study carried out amongst undergraduate medical students of 3 government medical colleges of Rajasthan, India. A validated 17 point, structured, questionnaire regarding use of smart phones, Mobile Applications most frequently used, usage pattern in terms of frequency and, perceived advantages and barriers. Data was analyzed employing SPSS. Results: Among the study population of 342 participants, 99.7% owned smartphones mostly Android Phones. Common medical applications used by the students were Google/Wikipedia 86.6% ,Medical Dictionary Medscape 50 % .Students use smartphone both for entertainment and study purpose and 82.4 % find smartphones as a useful aid in learning .Only 13 % find it as Useless and distraction. More than 57 % students, reported to have technological skills to use smartphones for medical education, communication and instant access during bedside teaching. Major advantages were access current information 69 % and anytime /anywhere access 23%. Major barriers to learning were slow speed 57 %. Conclusion: Use of Smartphone in medical learning is very popular and rapidly advancing and most medical students believe a smartphone would be a useful addition to their education, although barriers need to be overcome before the device is more unanimously recognized.
| » OTHO-17: Effectiveness of Ayurvedic Intervention in Reduction of Spasticity in Children with Cerebral Palsy | | |
Arun Raj GR, Shailaja U, Prasanna N Rao, Muralidhar P Pujar, Sreelekshmi, Kavya Mohan
Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India
E-mail: [email protected]
Objectives: To evaluate and compare the effectiveness of Salavana Upanaha Sweda with and without Parisheka on spasticity in children with cerebral palsy. Materials and Methods: 38 diagnosed cases of Spastic Cerebral Palsy were selected for the study based on the diagnostic criteria and inclusion criteria, later divided into two groups (A and B). The subjects in group A was administered both Pariseka and Upanaha while those in group B with Upanaha only. The duration of study was 90 days, in consecutive 3 sittings of 15 days each with gap of another 15days. Results: Both the groups showed effect in reducing Spasticity at the level of p<0.05. Conclusion: Although both groups were found to be effective in reducing Spasticity, better effect was seen in Upanaha along with Parisheka group when compared to the Upanaha alone group.
Keywords: Cerebral palsy, parisheka, salavana upanaha sweda, spastic cerebral palsy, spasticity, upanaha sweda
| » OTHO-18: Drug Utilization Study in Special Neonatal Care Unit of a Tertiary Care Teaching Hospital | | |
Parmar SK, VM Motghare, Sawant NG
Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, india
E-mail: [email protected]
Background/Objective: Neonates are among the most vulnerable populations to contract illnesses. As neonatal drug handling is different from adults, close monitoring of drug prescriptions is necessary. However, majority of drug utilization studies focus on adults & children. Limited data is available for neonates, so this study was undertaken to study drug prescription trends in neonatal care unit of tertiary care institute. Materials and Methods: This was a prospective, observational study in which data were collected from prescription records of all patients admitted from November 2014 to May 2016, in Special Neonatal Care Unit (SNCU) of Government Medical College, Nagpur. Results: Data were collected from 200 patients admitted in SNCU. A total of 1328 drugs were prescribed, parenteral route being the most common. 98.26% of patients received at least two or more drugs. 71.15% generic names & 28.85% drugs with brand names were prescribed. Average number of drugs prescribed per patient was 5.65. Percentage of patients receiving antibiotics was 95%. Conclusion: Study showed high drug exposure of neonates during first week of life which appears to be due to higher risk of neonates to infections. The study gave an overall pattern of drug use profile in tertiary care SNCU reflecting the problems for which neonates were admitted.
| » OTHO-19: A Study of Drug Utilization Pattern in Neonatal Intensive Care Unit) in a Tertiary Care Hospital | | |
Gavimath Neeta, Vasant R Chavan, Mohammad Arshad, Raghunandan M, Mohammad Faizuddin
Department of Pharmacology, Raichur Institute of Medical Sciences, Raichur, Karnataka, India
E-mail: [email protected]
Background: Neonatal intensive care management (NICM) may be required for high risk or critically ill neonates for survival or stabilization along with use of different classes of drugs. The pattern and extent of drug utilization may vary considerably in different regions of countries according to the prevailing perinatal / neonatal problems and complications, which need a systematic evaluation. Since there are a very few systematic studies and reports from Indian hospitals regarding the overall pattern and extent of drug utilization in NICM, the present study is taken up with the purpose of generating some valid data and useful information for improving the quality of neonatal care. Objectives: To study the pattern of drug use in Neonatal intensive care management (NICM), criteria for drug selection and dose individualization, to assess the efficacy and safety of medications and record drug interactions. Methodology: The pattern of drug use was assessed prospectively in 500 consecutive subjects admitted to NICU. The number of drugs used, therapeutic class, dose, route, frequency and duration of administration, the purpose of use, and criteria for selection were recorded. The efficacy and safety of the medications was assessed by the treatment outcome and observing for any adverse events or drug interactions. Results: Different therapeutic classes of drugs were used as per the prevailing clinical conditions or complications. The Total number of drugs from different classes available for prescription was 18, with an average of 3.6 per subject. Antimicrobial agents (AMAs) were the most commonly used drugs, chosen empirically and used in combination for prophylaxis or control of infections. Other classes of drugs were used for specific indications. The treatment outcome was very good in most of the subjects and no drug related adverse events or interactions were observed. Conclusion: Most Of The Problems And Complications In High Risk And Critically Ill Neonates Can Be Prevented Or Controlled By Judicious Use Of Several Classes Of Drugs, Properly Chosen And Individualized To The Given Situation, Without Producing Serious Adverse Events And Interactions. Drugs Play An Important Role In Improving The Outcome.
Keywords: Antimicrobial agents, NICM, NICU
| » OTHO-20: Pharmacovigilance in Geriatric Patient-A Prospective Observational study in a Tertiary Care Hospital | | |
Sahoo Satyabrata, Pattnaik KP, Maharana DN, Mohanty S, Mohapatra N, Dehury S, Swain TR, Das P, Samal R, Panda RK, Upadhaya R, Mishra KHP, Sahoo SS
Department of Pharmacology, S.C.B. Medical College and Hospital, Cuttack, Odisha, India
E-mail: [email protected]
Background and Objective: Physiological & Pathological changes are observed in Geriatric population that can alter Pharmacokinetics & Pharmacodynamics of administered drugs . Hence there is increased risk of Adverse Drug Reactions (ADRs). Limited studies conducted regarding this in India & no such study in Odisha.Hence this pharmacovigilance study in Geriatric patients is taken up in our tertiary care Hospital. Methods: This Prospective observational study was carried out in S.C.B Medical college & hospital, cuttack, from june to November 2017. Geriatric patients (Age>60 yrs) presenting either to Geriatric OPD or IPD of other departments with suspected ADRs were included, the detailed informations were filled up in Suspected ADR Reporting form of PvPI . The causality assessment done by WHO UMC SCALE & severity by HARTWIG'S SCALE. Results: A Total of 51 ADRs were reported in 5 months. Most common ADR was OHA induced Hypoglycaemia. The common Comorbidities were Hypertension (17.6%) followed by CKD (11.7%). Most commonly 76.4% ADRs were classified as PROBABLE according to WHO UMC SCALE. The severity assessment revealed that 29.5% of ADRs found to be Mild, 58.8% Moderate & 11.7% Severe. In contrast to 51 ADRs found in this study, only 29 ADRs reported in Previous 5 months (from January to May 2017). Conclusion: OHA induced hypoglycaemia was the most common ADR detected in our geriatric patients.70.5% ADRs were Moderate-severe in intensity. Active surveillance nearly doubled the reporting of ADRs.
| » OTHO-21: Introduction of Integrated Teaching of Pharmacology and Forensic Medicine | | |
Monica Jain, Deepali Pathak, Rupa Kapadia, Lokendra Sharma, Shivankan Kakkar
SMS Medical College, Jaipur, Rajasthan, India
E-mail: [email protected]
Objectives: To impart better understanding of medicolegal Emergencies, integrated teaching of Pharmacology with Forensic Medicine was introduced for teaching some topics and the student's perception was obtained for this horizontal integration. Methods: Horizontal integration of Forensic Medicine was implemented during Pharmacological teaching for four topics after formulating integrated teaching modules through inter departmental collaboration. Sedative hypnotics, common drug poisonings, opioid drugs and anaesthetic agents were taught to 229 students of Batch 2015 in 5th semester through four teaching sessions of two hours each. After completion of all modules the students perception was obtained with the help of a five point Likert scale on a pre validated questionnaire. Feedback for this integrated teaching module was also obtained through open ended questions in the questionnaire. Results: 72.9% students appreciated the method and 67.8% students had an opinion that this imparted better understanding of the topic. The median score for most questions was between 3 and 4. More than 50% students scaled this at 4 or 5 in terms of usefulness, better teaching method, more interest generation and active participation. 93% students recommended that this method should be used for teaching in routine. Positive response was obtained from more than 60% students in open ended questions too. Conclusion: The results highlighted that this integration can help the students to achieve a better understanding of practical implementation of these medical problems in their day to day practice. Although immense planning and inter departmental collaboration are essential for implementing such innovative methodology but purr results showed that the efforts are worthwhile.
| » OTHO-22: Study on Cost Analysis between Different Brands of Oral Anti-epileptic Drugs Available in India | | |
Konnur SS, Kishore MS
Department of pharmacology Mysore Medical College and Research Institut, Mysore, Rajiv Gandhi University, Bengaluru, Karnataka, India
E-mail: [email protected]
Objectives: To list the available dosage forms in different strengths of various antiepileptic drugs marketed in India. Aim: To calculate and evaluate percentage cost variation of individual formulation of drug manufactured by different companies and different dosage forms and formulation of the same drug by cost/defined daily dose (DDD) method and to identify less costlier antiepileptic. Methods: Cost of a particular drug being manufactured by different companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” OCT –DEC 2017 . The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and the percentage cost variation was calculated. The price was measured in Indian rupess (cost/DDD units). The percentage cost variation of drug due to different formulations was also calculated using minimum and maximum cost/DDD. The cost of each drug were also estimated as mean cost per DDD considering different formulation cost. Results: There is wide variation in the prices of different brands of same antiepileptic agents in Indian market. The highest % cost variation was found for Diazepam 5mg tablet (374.42), followed by Lorazepam 2mg tablet (213.63), Carbamazepine 100mg syrup/5ml-100ml (172.58), Levetiracetam 1000mg FC-tablet (168.57), Lamotrigine 25mg DIS- tablet (150), Clobazam 10mg tablet (147.37), Clonazepam 0.5mg tablet (140), Divalproex Sodium 500mg ER tablet (121.73), Oxcarbazepine 150mg tablet (89.46), Gabapentin 300mg capsule (71.67), Valproic acid 200mg FC-tablet (58.62), - Topiramate 50mg tablet (41.66) and lowest % cost variation was of Phenytoin Sodium 300mg tablet (3.46). Conclusion: There was a high-cost variation of antiepileptic drugs. It shows need for conducting pharmaco economic analysis. The prescribers and patient should be educated about drug prices. To counter act such cost variation, physicians should be encouraged to prescribe drug brand with low cost. This in turn reduces the unnecessary economic burden to the patients. To overcome this government has to change the pricing policy of medicine.
| » OTHO-23: Study of Knowledge, Attitude, and Practices Towards Current Updates of Pharmacovigilance and Adverse Drug Reaction Reporting among Doctors in a Tertiary Care Teaching Hospital of Western India | | |
Mistry CB, Shah SM, Mistry SD
Department of Pharmacology, Medical College Baroda, Vadodara, Gujarat, India
E-mail: [email protected]
Background: Adverse drug reactions (ADRs) are global problems causing both morbidity and mortality. Spontaneous ADR reporting is important to monitor adverse effects of medicines but under reporting is still very prevalent so, there is a need of constant monitoring and rectification of system of Pharmacovigilance. Objective: The objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about Pharmacovigilance and to identify the reason for under reporting of ADRs. Methodology: A cross-sectional study was carried out using a pretested questionnaire among doctors with minimum qualification MBBS or B.D.S. including faculties, senior and junior residents. Subsequently, analysis of association between education and experience was done by chi square test at P-value < 0.05. Results: A pretested questionnaire was distributed among 403 doctors and 240 (59.16%) responded voluntarily. In general, 131(54.58%) participants noted lack of time to report ADR while 90 (37.50%) participants noted no benefit of reporting already known ADR. On the other hand, total 104 (43.33%) participants were aware about need to report a serious adverse event during “Clinical Trial” within 24 hours to the Ethics Committee. Only 87 (36.25%) participants noted a need of reporting of already known ADR. Conclusion: Participants had good knowledge and attitude towards pharmacovigilance, but the actual practice of ADR reporting is still deficient among them that can be improved by sensitization training and involvement of grass root level health care workers.
Keywords: Adverse drug reactions, attitude, doctor, knowledge, pharmacovigilance, practice, questionnaire
| » OTHO-24: Knowledge and Perception towards Pharmacovigilance and Adverse Drug Reactions Reporting among Medical Students at a Teaching Hospital in South India | | |
Akshay JK, Hemanth Kumar KH
Department of Pharmacology, Mysore Medical College and Research Institute, Mysore, Karnataka, India
E-mail: [email protected]
Objectives: The objective was to assess the knowledge and perception towards pharmacovigilance and adverse drug reactions monitoring. Methodology: The study included undergraduate medical students of second, pre-final and final years of Mysore Medical College. A KAP based questionnaire was designed validated and standardized post pilot study which included the post graduates and faculty members of department of pharmacology, MMCRI. The questionnaires were distributed to all students. Willingness to answer and complete the questionnaire was considered as consent. Results: The questions were statistically analyzed individually and compared. Q1-Q10 compared knowledge towards pharmacovigilance, Q11-Q20 on the attitude and Q21-Q23 on the practice of ADR reporting. 325 questionnaires were distributed of which only 280 consented (second year – 114, prefinal – 98, final – 68).11 2 (49.1%), 137 (69.9%) and 79 (58.1%) of the three groups respectively knew what pharmacovigilance and ADR is. 79.8%, 76.5% and 75% knew who can report ADRs while 18.4%, 32.7% and 33.8% did not know what ADRs to report. 73(64.1%); 93(81.6%), 18(18.4%); 69(70.4%), 13(19.1%); 37(54.4%) knew the existence of AMC in the institute and the PvPI respectively. More than 92% agreed that ADR reporting is necessary, with about 70% agreeing that it is better learnt when taught clinically. Majority (>90%) agreed that PV and ADR reporting should be taught to all health care students while 28%, 30% and 54% said that it was not well covered in their curriculum.73(64%), 51(52%) and 63(93%) were not familiar with the ADR reporting form. Conclusion: Pharmacovigilance and ADR reporting need to be made compulsory, dealt more in detail for the students so that they can practice it with confidence in their clinical practice to ensure patient safety.
| » OTHO-25: Comparison of Causality Assessment Tools for Suspected Adverse Drug Reactions in Hospitalised Patients at a Tertiary Care Hospital | | |
Parikh CD1, Desai CK1, Shah MK1, Kapadia JD1, Desai MK1, Shah AN2, Patel SA2, Parmar K2, Sharma S2
1Department of Pharmacology, B.J. Medical College, 2Department of Medicine, Civil Hospital, Ahmedabad, Gujarat, India
E-mail: cparikh09gmail.com
Objective: Studies show poor agreement between three approaches of causality assessment of adverse drug reactions (ADRs) i.e. expert judgement, algorithms and probabilistic methods. This study aims to evaluate and compare different causality assessment tools for suspected ADRs reported in hospitalised patients. Methods: This was an observational, prospective, analytical single Center study carried out at Civil Hospital, Ahmedabad. All admitted patients with even indoor number in two randomly selected medical units were monitored for occurrence of ADR. Patients with suspected ADR were enrolled. The causality of ADRs was analysed by six experts (4 Clinicians and 2 Pharmacologists) through Visual Analogue Scale (VAS) and WHO-UMC scale. The investigator analysed causality by the algorithms namely Naranjo scale, Scales of Koh et al (2008), Karch and Lasagna and the French method. Agreement between different tools was calculated by Cohen's kappa and Fleiss kappa, as applicable. Results: A total of 50 patients with a suspected ADR from a total 869 patients were enrolled. Prevalence rate of ADRs was 5.75. Highest number of ADRs was from “Skin and subcutaneous tissue disorder” (26%). Most common drug group causing ADRs was anti-microbials. There was a moderate to substantial agreement (k=0.485-0.691) among different algorithms. The disagreement in causality by VAS and WHO-UMC (k=0.095) was much higher than that with algorithms. There was fair agreement between WHO-UMC scale and algorithms (k=0.08-0.225). Inter-rater agreement in WHO-UMC scale (k=0.44) was more than that observed with VAS (k=0.255). Conclusion: Inter-rater agreement was moderate for WHO-UMC scale. A combination of tools is recommended for an accurate judgement of causality of ADRs.
| » OTHO-26: Awareness about Online Pharmacy in Healthcare Professionals at a Tertiary Care Centre - A Knowledge, Attitude and Practice Study | | |
Patil DR, Joshi AD, Gambre RS, Patel SB
Department of Pharmacology, Grant Government Medical College and Sir J. J. Group of Hospitals, Byculla, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To assess the awareness about online pharmacy in healthcare professionals at a tertiary care hospital. Methods: After obtaining institutional ethical committee approval, 100 healthcare professionals were assessed for awareness about online pharmacy through a KAP questionnaire consisting of 10, 10, 5 questions related to knowledge, attitude and practice respectively. The data was compiled and analyzed using Microsoft Excel. Results: About knowledge, 20% were cognizant about the concept of online pharmacy. Awareness about advantages and disadvantages of online pharmacy was observed in 60%. 50% identified it as unregulated in India. 50% were aware about cyber doctors in online pharmacy.For attitude, 40% opined that conventional pharmacy has shortcomings. 46% and 60% believe that online pharmacy will play no role with regards to augmentation of pharmacovigilance and addressing the issue of antibiotic resistance respectively. 66% thought that it would cause increased drug abuse. 62% and 56% were worried about the data misuse and transaction safety. Cyber doctors were undermined by 68%. Conventional pharmacy is preferred over online by 58%. 48% opined that online pharmacy should be regulated in India and 44% anticipate it to be a success.Regarding practice, 28% had used online pharmacy; 52% have encountered others using it. 42% were against recommending it. Conclusion: In the current era of digital world, knowledge about online pharmacy is very less with hesitant attitude which may result in its misuse as well as underuse. Therefore, educating the population about online pharmacy is need of the hour before regulating it.
| » OTHO-27: A Study on the Evaluation of Medical Students' Perception and Feedback of Teaching-Learning of Pharmacology in a Medical College | | |
Mukku LS, Alla J
Department of Pharmacology, NRI Academy of Medical Sciences, Guntur, Andhra Pradesh, India
E-mail: [email protected]
Objective: Medical students perception on teaching and learning of pharmacology in our institution. Methods: This is a cross-sectional study conducted in a medical college after obtaining Institutional Ethical Committee approval. A pre-validated, predesigned questionnaire containing 23 points was administered to second year medical students. Results: Analysis was done on 150 students.Among them 86.62% wanted the faculty members to make more use of Audio-Visual aids for effective learning. 79.34% students wanted to include case based learning in the curriculum and 85.46% students wanted more of the clinical pharmacology to be introduced in the curriculum. 86% participants wished recent advances in the curriculum and 73% wanted MCQs to be included in assessment of academic performance. 8.62% students were willing to consider pharmacology as one of the subject in post graduation. 19% students ideal teaching method for learning pharmacology was didactic lectures and group discussions and 80% thought ideal teaching/learning media for pharmacology was the combination of LCD projector and blackboard. Conclusion: The study revealed the perception of the students in learning pharmacology were positive and constructive and the priority areas for improvement in teaching and learning methods in Pharmacology.
Keywords: Medical students, methods, teaching pharmacology
| » OTHO-28: Evaluation of NF-kß Inhibitor- Lansoprazole in Experimentally Induced Inflammatory Bowel Disease in Rats | | |
Purohit MD, Gupta PR, Shah HM, Gandhi TR
Department of Pharmacology, Anand Pharmacy College, Anand, Gujarat, India
E-mail: [email protected]
Objective: To evaluate NF-kβ Inhibitor-Lansoprazole in Experimentally Induced Inflammatory Bowel Disease in rats. Methods: Either sex Sprague Dawley rats were randomly allocated to 6 groups (n=6). Animals of Group I (Normal control), Group-II (Model control), Group-III and Group IV-VI were given STD group received:5-aminosalicylic acid (100mg/kg,) and Lansoprazole (1, 5 and 10 mg/kg, respectively, for 18 days once a day orally. colitis was induced with 2, 4- Dinitrobenzene sulfonic acid (DNBS) intracolonically in Groups-II -VI on day 11 of the study. During the study anthropometric parameters were recorded daily for each group.On 18th day, the animals were anaesthetized for blood collection to perform C-reactive Protein and were sacrificed, colon tissues were removed for evaluation of Colon mucosal index (CMDI), Disease activity index (DAI) and histological score. assessment of tissue myeloperoxidase (MPO), superoxide dismutase (SOD), malondialdehyde (MDA) and nitric oxide (NO) was performed in colonic tissue homogenate. Colon tissues were used for histopathology study.Results and Discussion: Lansoprazole exhibited significant reduction in CMDI, DAI, macroscopic and microscopic lesion score as well as significant (p<0.05) improvement in anthropometric parameters and antioxidant parameters. Furthermore, lansoprazole presented marked improvement in CRP level. Conclusion: Administration of lansoprazole could have significant therapeutic effects on the rat model of colitis induced by DNBS, which was probably due to the mechanism of antioxidation, inhibition of inflammation.
| » OTHO-29: In vitro Antioxidant and Glucose Uptake Assay on Lagenaria Siceraria (Bottle Gourd) and Luffa Acutangula (Ridge Gourd) Fruit Extract Belonging To Cucurbitacae Family | | |
Shendge PN, Belemkar S
Department of Pharmacology, School of Pharmacy and Technology Management, SVKM's NMIMS, Dhule, Maharashtra, India
E-mail: [email protected]
Objective: To investigate the in vitro antioxidant and glucose uptake properties of ethanol extracts of Lagenaria Siceraria (bottle gourd) & Luffa Acutangula (ridge gourd) fruit. Methods: The phytochemical screening of the extract was performed using standard procedure. The antioxidant activity of ethanolic extracts of Lagenaria Siceraria (Bottle Gourd) & Luffa acutangulata (Ridge Gourd) fruit was determined by using various in vitro assays such as DPPH, H2O2 assay & Thiobarbituric acid reactive substances (TBARS) assay. In vitro glucose uptake activity of fruit extract was determined by the everted intestinal sac method. Results: The phytochemical study showed that fruit extracts possess polyphenol, flavonoids, terpenoids in it. The results of the antioxidant properties showed that more than 60% of DPPH, HO. And LPO radicals were inhibited by both the extracts. The 50% inhibitory concentration (IC50) varied from 423.79μg/mL to 753μg/mL depending of the extract and the antioxidant tests. The results indicated that all the extracts exhibited antioxidant properties and the fruit of Lagenaria Siceraria antioxidant activity. Conclusion: The ethanolic extract of Lagenaria Siceraria (Bottle Gourd) & Luffa Acutangulata (Ridge Gourd) fruit possess good antioxidant & prevent absorption of glucose in everted intestinal sac.
| » OTHO-30: A Study to Evaluate the Perception of Undergraduate Students Towards Students' Corner as a Teaching Larning Tool | | |
Kurle DG, Parmar UI, Jalgaonkar SV, Bedrekar MS
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Maharashtra University of Health Sciences, Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
E-mail: [email protected]
Objectives: To evaluate the perception of pharmacology students towards students' corner as a teaching learning tool. Methods: The study was conducted in II MBBS students in the year 2013 to 2015 at department of Pharmacology & Therapeutics of Seth GS Medical College & KEM Hospital, Mumbai. At the beginning of their course they were briefed about this activity and they were asked to prepare interesting articles by using creativity on pharmacology topics already covered in the lecture in the form of mnemonics, puzzles, diagrams, flow charts, case studies, MCQs etc. A pre-validated questionnaire was given to students at the end of the year, to assess opinion & take suggestions about this activity. Results: Total 330 students answered the questionnaire. 76.1 % students thought contents were relevant, 67.16 % said the information was clear & understandable and 68.81% students were satisfied with the overall quality of articles. 72.73 % said that they enjoyed participating in the activity & 94.96 % opined that the activity should be continued in the future. But relatively few students thought that it has improved their confidence (56.14 %) & it will reflect in their performance (60 %). This activity received less score as compared to routine activities (tutorial, lecture and practical) and other supplementary activities like mannequin, video assisted learning and revision tests. But it was rated better than students' symposium, e-learning and terminal exams. Conclusion: Supplementary activities like students' corner can be a useful tool in learning volatile subject like pharmacology.
| rhamnosus GG (probiotic) Loaded Vaginal Dosage form for the Treatment of Aerobic Vaginitis"> » OTHO-31: Investigation of Lactobacillus rhamnosus i>(probiotic) Loaded Vaginal Dosage form for the Treatment of Aerobic Vaginitis | | |
Pednekar K, Fernandes C, Gupta GL
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: The role of probiotic Lactobacillus species in the treatment of vaginal infections has been well documented. By the use of prebiotic polymer in conjunction with probiotic it is possible to re-establish the normal micro flora of the vagina. Hence, the objective of this investigation was to evaluate Lactobacillus rhamnosus GG (probiotic) loaded biodegradable vaginal dosage form. Methods: Different batches of Lactobacillus rhamnosus GG (ATCC 9535) loaded vaginal dosage form were prepared using internal cross linking technique by extrusion technique under sterile conditions. The vaginal dosage forms were characterized for morphology, loading efficiency, release profile, bacterial viability at different vaginal pH (pH 4.5, pH 5.5 and pH 6.5), protein adsorption, hemo-compatibility study, in vitro hydration and, in vitro as well as ex vivo antimicrobial studies against Escherichia More Details coli (E.coli). Results: The result obtained by scanning electron microscopy (SEM) showed rod shaped Lactobacillus rhamnosus GG species internal cross linked in vaginal dosage form. The vaginal dosage form was found to be containing approximately 109 CFU/ml of Lactobacillus rhamnosus GG species. The dosage form also showed consistent release of Lactobacillus rhamnosus GG at different time points up to 48 hours. The protein adsorption for the dosage form was found to be 51.93% and showed excellent hemo-compatibility property. Lactic acid bacteria loaded vaginal dosage form also demonstrated significant zone of inhibition (15 mm±3 mm) against E.coli on triplicate experiments. Conclusion: The formulated biodegradable vaginal dosage form has potential antibacterial activity against E.coli and, can be considered for the management of aerobic vaginitis
Keywords: Aerobic vaginitis, bacterial vaginitis, implant, biodegradable device, lactic acid bacteria, Lactobacillus rhamnosus GG
| » OTHO-32: Pattern of Adverse drug Reactions in Patients Receiving Antituberculosis Drug Over a Period of 6 Months in A Tertiary Care Hospital | | |
Chaudhari AF, Parmar DM
Department of Pharmacology, M. P. Shah Government Medical College, Jamnagar, Gujarat, India
E-mail: [email protected]
Objectives: To study and analyse the various adverse reactions occurring in patients receiving antituberculosis drugs in a tertiary care hospital, Jamnagar. Methods: A prospective, observational study was carried out for duration of 6 months (January 2017-June 2017). Necessary data regarding adverse drug reaction and relevant treatment were collected from Tuberculosis and Chest department in a tertiary care hospital. ADR reporting forms issued by CDSCO were used to record the ADRs. Causality, severit and preventability were assessed by WHO causality assessment scale, Hartwig and seigels scale & Shumock and Thornton scale respectively. All ADRs were uploaded and reported for central assessment in vigiflow. Results: Total 52 ADRs were due to antitubercular agents during this period. Out of 52 patients 11 (21.15%) were females and 41(78.84%) were males. The most commonly affected system was gastrointestinal tract 39 (75.00%), followed by skin 4 (7.69%). In Anti tubercular agents, Rifampicin and Pyrazinamide 30 (57.69%) were most common Antitubercular agents responsible for ADRs. According to WHO causality assessment most of the ADRs were “possible” 18(34.61%), followed by “probable” 34(65.38%) and By Hartwig and seigels scale ADR were “mild adrs”27(51.92%), “moderate adrs” 19(36.53%), “severe adrs”6(11.53%) & “. Shumock and Thornton scale shows 52(100%) were “not preventable” and 0 was “preventable”. Conclusion: Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects.
Keywords: ADRs, causality assessment scale, CDSCO form
| » OTHO-33: Cost of Illness in Type 2 Diabetes Mellitus Patients | | |
Bagle TR, Vare VA, Hire RC, Nimgade A, Kshirsagar P, Sharma Y
Department of Pharmacology, Maharashtra University of Health Sciences University, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane, Maharashtra, India
E-mail: [email protected]
Objectives: To evaluate total, direct and indirect costs in type 2 diabetic patients. To evaluate cost of medications, types of medication, difference in cost of different brands, in type 2 diabetic patients. Methods: A Cross-sectional Randomized study of 100 type 2 diabetic patients that attended Medicine OPD of a tertiary care hospital. Institutional Ethics Committee permission was taken. Informed consent was taken and demographic information related to Education, Occupation and Income, Information related to diagnostic tests and medications were documented. Inclusion criterion were 18-65 years of either gender diagnosed by Physicians in OPD as type 2 diabetes, willing to participate and have followed in OPD for at least one year. The Exclusion criterion was critically ill or unconscious patients, pregnant women. Results: The average age was 54.88± 9.67 years. The average fasting blood glucose was 153.52 ± 27.86. The average cost per month for investigations was 199.13 ± 97.32. Annual visit to OPD was 14.11 ± 9.25. Time loss per visit was 6.21 ± 2.12 hours and of accompanying person 7.65 ± 4.07. There were 2 from Lower and 63 from Upper Lower socioeconomic class. There were 41 patients having diabetic complications. The indirect cost was around 13,153 and direct cost was around 19,925. Total cost per year per patient was around 33,078. Conclusion: There is need for health insurers, policy makers and other stakeholders to form strategies to reduce the cost burden. Thus there is need to design financial systems for diabetes related nationwide health programmes.
| » OTHO-34: Effectiveness of a Module to Promote Competency in Adverse Drug Reaction Reporting in Undergraduate Medical Students | | |
Sharma N, Sharma T, Bala S
HIMS, SRHU, Dehradun, Uttarakhand, India
E-mail: [email protected]
Background: Adverse drug reaction (ADR) under-reporting is a hindrance to the implementation of Pharmacovigilance Program of India. This is essentially due to lack of, ADR reporting culture among healthcare professionals. Thus study was conducted to assess and enhance awareness about ADRs and strengthen reporting among medical undergraduates. Methodology: This is an interventional crossover study. A total of 140 students of 2nd professional, MBBS were included and divided into two groups of 70 each. In phase 1, group A was given a didactic lecture (DL) on ADR and pharmacovigilance. Group B was also given DL with an addition of a case narrative exercise and they were asked to fill an ADR form. Both groups were assessed based on an MCQ questionnaire for knowledge and skill. After 15 days of washout period, groups were crossed and reassessed. Feedback from students was taken on a 5 point Likert's scale. Results: The mean scores of batch A without case was 17.5 ± 3 out of a total score of 25 marks, which showed improvement with case narrative and mean increased to 19.6 ± 2.4 (p < 0.05). Similarly, Batch B showed improvement as well and the mean 17.7 ± 3.1 score without case narrative increased to 19.2 ± 2.7 (p < 0.05). Student's perception of the effectiveness of module based teaching was positive.Conclusion: Case narrative in addition to didactic lecture enhanced awareness and may strengthen ADR reporting culture among the medical students.
Keywords: Adverse drug reaction, pharmacovigilance, teaching module
| » OTHO-35: Awareness among the Undergraduate Medical Students of RIMS Regarding Handling of Experimental Animals | | |
Kumar T, Dutta G, Paonam SD
Department of Pharmacology, Regional Institute of Medical Sciences, Manipur University, Imphal, Manipur, India
E-mail: [email protected]
Objectives: To determine the awareness among the undergraduate medical students regarding handling of experimental animals. To determine the factors associated with awareness regarding handling of experimental animals. Methods: Many hours in undergraduate practical training in the discipline of Pharmacology presently are spent in animal experiments. With this background the study was conducted to determine the awareness with a cross sectional study in RIMS, Manipur from 1st Jan to 7th Jan 2018 including all the MBBS and BDS students from 3rd semester to 9th/8th semester respectively. Sample size and sampling - Intended to cover the whole population. Data collection: Prior to the study initiation, an informed verbal consent was be taken from the students. The participants were briefly explained about the study and its importance and asked to join the same. The data was collected by questionnaire method. Data were entered in SPSS 21 version software for windows. Descriptive statistics were used. Chi square test was used to test for association between proportions of the data and p value of <0.05 was considered significant. Approval was obtained from the Research Ethics Board, RIMS, Imphal.Results: 57.7% students were male participants. 83.5% students were found to have inadequate awareness. MBBS students were found to have more awareness than BDS and was statistically significant with p-value of 0.013. Conclusions: Eight out of ten students were found to have inadequate awareness regarding handling of experimental animals. MBBS students were found to have more awareness than BDS and was statistically significant.
| » OTHO-36: A Comparative Evaluation of Different Integrated Teaching and Learning Methods among Medical Students to Improve the Knowledge of Pharmacology | | |
Rani M, Sharma L, Sharma S, Sharma K, Upadhayay A, Yadav D
SMS Medical College, Jaipur, Rajasthan, India
E-mail: [email protected]
Introduction: This study was conducted to evaluate the different teaching methods, recitation/ lecture method, questioning/ Socratic Method and inquiry method in medical students of S.M.S. Medical College, Jaipur. Methods: Total 200 students of the second year M.B.B.S. included in the study. Students were taught pharmacology aspect of anti-cancer drugs and antihistamines drugs through three different methods like recitation/ lecture method, questioning/ Socratic method and inquiry method. After few days 15 item self- administered performa was distributed to the students to check their retention effect. After compilation of collected data, the analysis was done using Statistical Package for Social Sciences (SPSS). Results: The mean age of students was 20.31±2.94 years and 60% males and 40% females.55% students choose inquiry method, 28% choose questioning /Socratic method and only 17% in favor of recitation method for better understanding of pharmacology concepts. About 65% students think that for remembering drugs and their mechanism best method is socratic method. Most of the students found that both inquiry and socratic method introduce problem -based learning. According to 70% students, the questioning method creates a positive learning environment in the classroom. 60% students were in favor that questioning method is constructive and interactive. 65% students were preferred the questioning method to teach pharmacology. During the study students were also given some suggestions, 80% suggested that to change the order of pharmacology topics taught. 90% students gave the suggestion that pharmacology should be taught by correlating with clinical cases. Conclusion: During the study, it was concluded that there is need to develop innovative teaching -learning methods and include more of clinical pharmacology in the undergraduate pharmacology subject.
| » OTHO-37: Adverse Reactions Profile to Chemotherapy Drugs in Oral Cancer Patients: A Prospective Single Centre Study | | |
Sharma Kopal, Sharma Lokendra
Department of Pharmacology, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan, India
E-mail: [email protected]
Objective: Chemotherapy improves outcome in cancer patients and ensures an improved quality of life. Monitoring the adverse effects during chemotherapy is extremely beneficial as it ensures safety of the patient. Methods: This prospective study was carried out among the out patients of oncology ward of SMS Medical College, Jaipur, over a period of six months. The Institutional Ethics Committee approval was obtained prior to the initiation of the study. Oral and oropharyngeal cancer patients belonging to either gender and of 20-70 years, who were receiving chemotherapy under standard regimen, were included. Adverse drug reactions were assessed for causality using WHO causality assessment scale. Severity of ADRs was assessed using modified Hartwig and Siegel scale. The predictability and preventability of the reported ADRs were assessed using developed criteria for determining predictability of an ADR and Modified Schumock and Thorton Scale respectively. Results: Out of 110 patients, 95 (86.4%) patients were males. 44 patients during the study developed adverse drug reactions. WHO UMC causality assessment of Paclitaxel+carboplatin regimen showed 82% of ADRs were “definite” and 18% were “probable”. Hartwig and Siegel severity assessment showed 98.2% were 'mild' and 1.8% were of 'moderate' type, Modified Schumock and Thornton scales of preventability showed 100% were “not preventable” ADRs. Conclusion: From this study it was evident Paclitaxel and Carboplatin regimen administered to patients here have few, mild adverse effects. Further patients receiving chemotherapy drugs should also be motivated to further report any adverse drug reactions to further strengthen pharmacovigilance program in our country.
| » OTHO-38: Aerobic and Anerobic Fitness among Young Adults Sabahan Population of Malaysia | | |
D'Souza UJA, Vinod S, Hossain TP, Choudhary SS, Murthy D, Ahmed FA
Faculty of Medicine and Health Sciences, University Malaysia Sabah, Malaysia and MAHSA University, Kuala Lumpur, Malaysia
E-mail: [email protected]
Background: To establish a balance between work (physical exercise), the aerobic capacity (VO2 max) used as a measure. Subjective and physiological assessment, one of the methods for assessing physical exercise Previous study suggests black race is superior compared to white on aerobic and anaerobic exercises among sedentary population. Malaysia's state of Sabah multiethnic society the anthropometric and body composition vary and aerobic and anaerobic fitness may differ from the other races. Low aerobic fitness is associated with the cardiovascular diseases regardless of body composition. Anaerobic fitness is related with the fitness status among the young adults. Since Sabahan ethnic population anthropometry is not similar with the existing studies, this study evaluates BMI, Height, weight on aerobic and anaerobic capacity. Objectives: To establish a baseline data and its correlation such as BMI, Height, weight on aerobic and anaerobic capacity. Methods: Thirty subjects of either gender, 18-24 year College students, hostel diet, diverse ethnic backgrounds of Sabah. Demographic data obtained. Anthropometry, anaerobic (Monark 894E), aerobic capacity (Astrand) measured. Aanaerobic Wingate test using 7.5% of the body weight for 30 seconds with maximum RPM. Peak power and average power were calculated. Heart rate, blood pressure, metronome recorded. Scatter plot satisfies the assumption of zero mean and the normal probability plot shows the residuals as normally distributed. Results: Height, weight, BMI showed 47.6% of the variation with anaerobic peak power, 23.6% variation with the aerobic capacity; other predictor variable contributed more than 50%. P value (0.006) < 0.05 match for prediction for anaerobic power. Variables negatively correlated with the anaerobic peak power. Weight contributes the largest contribution of anaerobic power. The aerobic capacity is negatively correlated with the BMI, height and weight. Conclusions: The anaerobic capacity is less correlated with the anthropometry measurement and only weight of the subjects contributed much more than the other parameters. The aerobic capacity is not related with the anthropometry measurement and it could be explained by other variables. Conclusively the person's aerobic and anaerobic capacity is not predictable by means of anthropometry measurements such as BMI, Height and weight. There is no significant correlation between physical stature and aerobic and anaerobic capacity.
Keywords: Astrand protocol aerobic and anaerobic capacity, Wingate test
| » Poster Presentations Clinical Pharmacology | | |
| » CPP-1: Evaluation of Anti-obesity Activities of Tinospora cordifolia Stem and Commiphora wightii resin extract in Monosodium Glutamate –High Fat Diet Induced Obese Mice | | |
Mohanty Satyajit, Pattnaik Ashok, Kumari Sangita, Chakraborti Sanchari
Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Ranchi, Jharkhand, India
E-mail: [email protected]
Objective: To evaluate the anti-obesity activity of methanolic extract of Tinospora cordifolia stem and Commiphora wightii resin in monosodium glutamate (MSG) and high-fat diet (HFD) induced mice. Methods: Twenty five Swiss albino mice of both genders were divided into five groups. Group I – Normal Control, Group II – Obese Group (MSG+HFD), Group III – Standard Orlistat Group, 60mg/kg I.P. for 30 days, Group IV – Test Treatment Group 1 (Tinospora cordifolia), 50mg/kg I.P. for 30 days, Group V – Test Treatment Group 2 (Commiphora wightii), 20mg/kg I.P. for 30 days. After the end of experimental period the body weight, waist-hip ratio, food intake, organ weight and adipose tissue weight were estimated in experimental groups of animals. Biochemical parameters like (AST, ALT, VLDL, HDL, triglycerides, cholesterol) as well as histological examination was done. Results: The obtained results showed significant reduction in body weight (p<0.001), waist-hip ratio (p<0.01), changes in food intake (p<0.05), liver weight (p<0.05), brain weight (p<0.01), adipose tissue weight (p<0.05), Biochemical parameters SGOT (p<0.001 & p<0.05), SGPT ( p<0.05), Blood glucose level (p<0.001), TG & LDL (p<0.001), VLDL (p<0.05) when compared with obese control group. Conclusion: Tinospora cordifolia and Commiphora wightii have a significant anti-oxidant and α-amylase inhibitory activity confirmed by In-vitro studies. A significant decrease in body weight, fat mass, waist circumference, organ weight (Liver), biochemical parameters was confirmed by in-vivo evaluation and Tinospora cordifolia showed better potential anti-obesity activity from Commiphora wightii. From the present study, the chosen herbal drug could follow molecular mechanistic pathway and have potential for anti-obesity therapy.
| » CPP-2: Successful Treatment of Chronic Osteomyelitis of Calcaneum by Intravenous Linezolid | | |
Khan SS, Bhosle DS
Department of Pharmacology, MGM's Medical College and Hospital, Aurangabad, Maharashtra, India
E-mail: [email protected]
Background: Osteomyelitis in children is a potentially serious condition and has potential for lifelong disability and morbidity. The early diagnosis and appropriate treatment is critically important. The common causative organisms for chronic osteomyelitis are staphylococcus aureus, streptococci, H influenza and salmonella. In children with sickle cell anemia the most common organisms are salmonella. The collection of appropriate sample like discharging pus or even bone sampling for microbiological and pathological examination may allow choosing the most effective antibiotics. Methicillin resistant S.aureus which earlier used to be considered as nosocomial infection is increasingly being identified in community acquired infections. We present here a case of acute osteomyelitis caused by methicillin resistant staphylococcus aureus. The patient was a 8 year old male child with no significant past medical history was admitted with complaints of heel pain and inability to bear weight on affected limb since 4-6 weeks. Patient earlier took treatment from local physician who prescribed some oral medicine. There was no improvement in the pain and at the time of presentation to our institute the patient had more definitive signs of infection including fever and local tenderness and a discharging sinus. An MRI was done which revealed features of osteomyelitis in the form of sequester and soft tissue gas. Since the history was that of more than 1 month a diagnosis of chronic osteomyelitis was made and the discharging pus was sent for microbiological examination which showed growth of methicillin resistant staphylococcus aureus sensitive to linezolid. Patient was successfully treated with linezolid in appropriate doses. Objective: Our case emphasizes the importance of proper investigations (Imaging, microbiological and pathological examinations) and treatment with appropriate antibiotics in patients suspected to be having osteomyelitis. Conclusion: Chronic Osteomyelitis of calcaneum is an uncommon occurrence in paediatric age group. Its diagnosis is difficult in children because of its indolent course. High index of suspicion is necessary to diagnose it in early stages. X-ray may be normal in early stages and MRI is the investigation of choice. Methicillin resistant staphylococcus aureus is one of the commonly involved organisms. IV Linezolid can effectively treat this otherwise difficult to manage condition
Keywords: Chronic osteomyelitis, computed tomography, linezolid, methicillin resistant Staphylococcus aureus
| » CPP-3: Self Medication Practices and Attitude among Dental Students of a Metro City of North India | | |
Akram MF, Manak S, Inder D, Alvi S1
Departments of Pharmacology and 1Medicine, Faculty of Dentistr Jamia Millia Islamia (A central University by an act of Parliament), New Delhi, India
E-mail: [email protected]
Objective: Self-medication is a common practice all over the world and its consequences are cause of concern. The students studying medicine and dentistry are among the most vulnerable class for its practice. The study was to assess the extent and factors influencing self-medication among undergraduate dental students. Methods: A cross-sectional study was carried out, that included 1st, 2nd and 3rd year students of dental college .A questionnaire consisting of demographic questions and questions on knowledge attitude and practices of self medication in the last six months was prepared and given to the 67 students. Frequency analysis of 67 students has been done and being presented here and the study is continuing. Results: Of a total of 67 students 34 % reported at least one minor episode of an illness,(64%) of them practiced self-medication and 29.8% of the students also advised medicines to other. Most common source of advice was family and friends (43.2%) followed by books and internet 13.5% each. Most common self medicated drugs were paracetamol followed by cetrizine. Interestingly no one mentioned ORS for diarrhoea although Metronidazole, ofloxacin, ketokonazole and Monteleukast was mentioned by a few. Most Common reported illness for self medication were fever and headache (24.8%) followed by cough and common cold (23.9%). Conclusion: Prevalence of self-medication among dental students is high that needs to be intervened. Although it is difficult to stop the practice, academician and health professionals need to educate students about the rational use of drug and impact of irrational prescribing.
| » CPP-4: Cyclophosphamide and/or Anthracyclines Induced Epiphora in Breast Cancer Patients: A Rare Side-effect | | |
Kalra R, Chavada B1, Madhani NR1, Tripathi CB2, Purohit BM
Government Medical College, Bhavnagar, 1Government Medical College, Sir Takhtsinhji General Hospital, Bhavnagar, 2Rajkot Cancer Hospital, NP Cancer Institute, Rajkot, Gujarat, India
E-mail: [email protected]
Objective: To thoroughly evaluate two female breast cancer patients with rare adverse effect of epiphora after administration of cyclophosphamide and/or anthracyclines based 2-day chemotherapy regimen. Methods: Two female breast cancer patients developed epiphora after administration of cyclophosphamide and/or anthracyclines based 2-day chemotherapy regimen. An ophthalmologist was consulted and no apparent cause was found. Patients were managed by ciprofloxacin eye drops. Causality assessment was done by WHO scale and Naranjo's scale for suspected adverse drug reaction. Modified Schumock and Thornton's criteria for preventability and Modified Hartwig and Siegel's scale for severity was also done. Results: Causality assessment was done for both the cases which showed that suspected adverse drug reaction was probable while Naranjo's scale showed that the relationship between epiphora and cyclophosphamide and doxorubicin drugs was probable (Score 6) in one case and relationship between epiphora and cyclophosphamide and epirubicin drugs was possible (Score 2) in another case. According to Modified Schumock and Thornton's criteria, this reaction was not preventable and as per Modified Hartwig and Siegel's scale reaction was mild (level 1). Conclusion: Chemotherapy induced ocular complications are not uncommon, but under reported. Although epiphora is a mild reaction if severe can interfere with daily activities. Patients having chemotherapy induced ocular toxicity should go for ophthalmic examination to pick up ocular adverse effects of anticancer drugs and treat them at an early stage
| » CPP-5: A Study of Effect of a Single Dose of Second Generation Antihistaminics on Cognitive and Psychomotor Function in Healthy Human Volunteers | | |
Saxena K, Srivastava SK, Mehta C
Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India
E-mail: [email protected]
Objective: To assess whether second generation antihistaminic alter psychomotor and cognitive function in comparison with promethazine (marked sedation; altered psychomotor and cognitive impairment). Methods: It was a single blind prospective study. Seventy five healthy human volunteers were registered, divided in five groups. These groups have received placebo, promethazine 25 mg, cetirizine 10 mg, fexofenadine 120 mg and loratadine 10 mg. Cognitive and psychomotor functions were assessed pretreatment and 60 minutes after single dose of drug(post treatment) by using a battery of standard tests (e.g. PST-Perceptual speed test, BVRT- Benton visual retention test, SSS- Stanford Sleepiness Scale, FTT-Finger tapping test etc.). The data were analyzed by student's t-test and ANOVA. Results: No significant effect was observed in any test parameter with placebo and fexofenadine. Significant difference with promethazine in PST, BVRT, SSS and cetirizine in DSST, FTT and loratadine in DSST were observed. Significant difference was observed in DSST between the placebo and promethazine, in SSS between promethazine and all other drugs. In FTT and BVRT significant difference between the groups were observed. Conclusion: Significant sedation and altered cognitive and psychomotor function were observed with promethazine. Cetirizine and loratadine do not cause sedation but both affect psychomotor functions. No significant effect was produced by fexofenadine. Thus, fexofenadine can safely be used in persons involved in activity where alertness is required while cetirizine and loratadine should be avoided.
Keywords: Antihistaminics, cognitive function, psychomotor function, sedation
| » CPP-6: Evaluation of Rationality of Drug Promotional Literatures using WHO Ethical Criteria for Medicinal drug Promotion | | |
Mangla N, Gupta MC
Department of Pharmacology, Pt. B.D. Sharma University of Health Sciences and Research, Rohtak, Haryana, India
E-mail: [email protected]
Objective: To evaluate the rationality of drug promotional literatures (DPL) using WHO criteria for ethical medicinal drug promotion. Methods: 150 brochures for drug promotion were collected from physicians of various departments in Pandit B. D. Sharma University of health sciences randomly, to whom they were circulated by medical representatives. These promotional literatures were evaluated against the WHO ethical criteria for medicinal drug promotion. Results: Only 2% of the drug promotional literature fulfilled all the WHO criteria and none fulfilled OPPI Code of Ethical Practice. DPLs were highly compliant (≥ 70%) about brand name, active ingredients & their contents, manufacturer's name and address. DPLs showed moderate compliance (40-69%) regarding mention of approved indications and dosages but unfortunately majority of DPLs were poorly compliant (≤ 39%) for references, side effect, precaution, warnings, contraindications, interactions and name of other ingredients. Cost was mentioned in only 4% of literature and date of production of advertisement was not mentioned in any literature. Antibiotics (20%) were the most promoted group of drugs. 65% of promotional literature was designed for promotion of FDCs. Conclusion: Drug promotion undoubtedly influences the prescribing behaviour of general physicians but their accuracy has always been questionable because the facts and figures in these literatures are often biased and distorted so as to highlight only the beneficial effect of the products and undermine the harmful effects. At national level, ethical committees and drug regulatory authorities need to maintain stringent control on the promotional activities of the pharmaceutical companies.
Keywords: Drug promotion literatures, ethical drug promotion, WHO criteria
| » CPP-7: Assessment of Knowledge, Attitude and Practice of Pharmacovigilance among Clinicians and Postgraduate Students in a Teaching Medical Institution - A Questionnaire Study | | |
Dass AP, Desai S
Department of Pharmacology, GIMS, Kalaburagi, Karnataka, India
E-mail: [email protected], [email protected]
Background: Spontaneous voluntary adverse drug reaction (ADR) reporting is the backbone for the successful functioning of the Pharmacovigilance Programme of India. These study objectives were to assess the knowledge, attitude, and perception of clinicians and postgraduates towards adverse drug reporting and to suggest possible ways of improving this method of reporting.Materials and Methods: The study was a cross-sectional questionnaire-based study. The study participants consisted of all the healthcare professionals (doctors, and postgraduate students) who gave their informed consent and who were working at the hospital during the study period. KAP questionnaire was designed to assess the demographic details of the healthcare professionals, their knowledge of pharmacovigilance, attitudes towards pharmacovigilance, and their practice on ADR reporting. There were 13 questions in all (five related to knowledge, five related to attitude, and three related to practice). One question was asked to determine the reasons for underreporting. These questions were designed based on earlier studies for assessing KAP of ADR reporting. Results: This study shows an above average knowledge of pharmacovigilance amongst healthcare workers to be about 61.80% and attitude towards the same to be 70% which seems satisfactory but falls back a bit with regards to putting all that knowledge to practice accounting for 50%. In this study, there was quite a gap between those who had knowledge and attitude (>70%) on Pharmacovigilance and those who had practised it (<50%). Conclusion: This gap between knowledge, attitude and practice calls for immediate attention ,in the form of raising awareness amongst the clinicians, post graduate students ,nursing staff, interns and pharmacists and training them in ADR reporting.
| » CPP-8: The Effect of Lamotrigine Monotherapy on Sleep Quality in Patients with Epilepsy with Generalised Tonic-clonic Seizure: A Questionnaire Based Study | | |
Kumar A, Gupta MC
Pandit Bhagwat Dayal Sharma Post graduate Institute of Medical Sciences, Rohtak, Haryana, India
E-mail: [email protected]
Objective: The antiepileptic drugs (AEDs) have differing effects on sleep structure, which can be beneficial or detrimental. On the literature search, few studies have reported the influences of lamotrigine (LTG) as add on drug to the conventional first line AEDs. Our purpose was to evaluate the effects of LTG as monotherapy in epileptic patients on sleep quality by using questionnaire Pittsburgh Sleep Quality Index (PSQI). Methods: 30 patients were included in cross over fashion and were subjected to PSQI to have their baseline data. After recording the baseline data, all the patients were given LTG monotherapy. Patients were assessed for a period of 3 month for control of seizures. The patients in whom seizures were controlled were subjected to PSQI at the end of 3 months and observations were compared with baseline data using student paired t-test. Results: Treatment with LTG produced, there was significant increase in PSQI score (0-5) and non-significant increase in PSQI score (6-21) at the end of 3 months compared to baseline values. No patients reported insomnia with treatment. Conclusion: LTG appears to improved good sleeper (0-5) than bad sleeper (6-21) is statistically significantly hence LTG is less disruptive to sleep quality than some of the older AEDs.
| » CPP-9: Evaluation of pharmaceutical care for diabetic patients in the state of goa | | |
Dessai MA, Joshi MP, Mainkar AA
Department of Pharmacology, Goa College of Pharmacy, Panjim, Goa, India
E-mail: [email protected]
Objective: This study aimed at evaluating pharmaceutical care provided by community pharmacies for diabetic patients in the state of Goa. Methodology: Data was collected from pharmacists in community pharmacies, patients at diabetes camp., by conducting surveys in rural and urban areas. The qualitative and quantitative analysis of pharmaceutical care was assessed statistically based on records maintained, instructions and information provided and patient counselling by the pharmacist. Results: Total 133 pharmacy premises were surveyed to assess pharmaceutical care in Goa, The data included (A) Type and percentage of each type of diabetes mellitus, (B) Interaction between pharmacists and patients on various aspects of pharmaceutical care and patient counselling, (C) Frequency of detection of blood glucose levels by patients and experts, (E) BMI estimation of patients by pharmacists (F), Percentage of people depending on Allopathy, Ayurveda and Homeopathy (G) Percentage of people on oral hypoglycemics and insulin therapy. Conclusion: Diabetes mellitus being a chronic illness requires pharmacological and non-pharmacological care for better control, including patient compliance and pharmacist counselling. The study showed a qualitative and a quantitative difference in pharmaceutical care given to diabetic patients in urban and rural areas in Goa. It was revealed that Standard guidelines on pharmaceutical care for diabetic patients is the need of hour.
| » CPP-10: A Case of Isoniazid Induced Alopecia | | |
Jain C, Srivastava B, Belwal G, Punera DC, Bhardwaj R
Department of Pharmacology, Government Medical College, Haldwani, Uttarakhand, India
E-mail: [email protected]
Objective: Alopecia during Anti Tubercular Therapy (ATT) is very uncommon and previously observed with Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Thiacetazone and ethionamide. Therefore, the objective of this study is to report an Adverse Drug Reaction (ADR) caused by ATT. Methods: The patient in TB and Chest department reported an ADR by the drugs prescribed. The ADR was collected by the physcian and was filled in Suspected Adverse Drug Reaction Reporting Form (version 1.2) of Indian Pharmacoepia Commission (PvPI) and the data entered was interpreted and reported to PvPI via vigiflow. The report Id generated was 2017-50987. Case Report: We report a case of 24 years old female taking ATT (Isoniazid, Rifampicin, Ethambutol and Pyrazinamide) for pulmonary tuberculosis developing alopecia after 26 days of taking treatment. Drugs were not withdrawn and there was no recovery from alopecia. Results: Causality assessment was done using WHO scale and possibly Isoniazid was the suspected drug causing alopecia. Conclusion: According to previous studies, among all antitubercular drugs, Isoniazid is the most common drug causing alopecia followed by Rifampicin, Ethambutol and Pyrazinamide. Therefore physician should be aware of the adverse effects of the drug prescribed and report to the ADR reporting centre for the safe use of medicine.
Keywords: Adverse drug reaction, alopecia, anti tubercular therapy, indian pharmacopoeia commission, isoniazid
| » CPP-11: Montelukast Induced Churg–Strauss Syndrome (CSS) in Asthma Patient | | |
Patel A, Solanki Y1, Naik V1, Lakhani K1, Purohit BM1
Government Medical College, 1Government Medical College and Sir Takhtsinhji General Hospital, Bhavnag, Gujarat, India
E-mail: [email protected]
Introduction: Churg–Strauss syndrome (CSS) is a rare systemic vasculitis associated with asthma and eosinophilia. Incidence rate of Churg–Strauss syndrome CSS is up to 67 per million among patients with asthma who use Leukotriene receptor antagonist for the treatment of asthma. Case Presentation: A 20 year old female patient developed maculopapular rash on both forearm, diffused rhonchi present in both lungs, bilateral hand swelling and peripheral blood hypereosinophilia which suggest Churg–Strauss syndrome (CSS) which occurred due to administration of Montelukast for treatment of asthma. The reaction was confirmed by treating physician and our patient satisfy the diagnostic criteria of the American College of Rheumatology for diagnosing of CSS. Causative agents were stopped and patient was managed by systemic therapy. Patient was recovering after 72 hours. Conclusion: Increase awareness of prescribers for high-risk drugs, close monitoring, with immediate withdrawal of the culprit drug can reduce the complexity of management that occur due to development of such adverse drug reaction.
| » CPP-12: To Profile Side Effect of chemotherapeutic Agents in cancer patients | | |
Dange AS, Majumdar AS, Manjunath Nookala Krishna Murthy
Department of Pharmacology, Bombay College of Pharmacy, Mumbai, Maharashtra, India
[email protected]
Objective: The primary objectives of this study were to determine the adverse drug reactions of Pemetrexed + Platinum (Carboplatin) compounds doublet chemotherapy in palliative setting of non-small cell lung cancer at Tata Memorial Hospital (TMH) Parel, Mumbai. Methods: Inclusion criteria included, Patients of either gender aged ≥18, Patients histological diagnosed to non-small cell lung cancer, Patients receiving the first cycle of Pemetrexed + Platinum doublet chemotherapy. Treatment was pemetrexed 500 mg/m2 given intravenously and carboplatin area under the serum concentration–time curve = 5 or 6 given intravenously on Day 1 every 3 weeks for four cycles; patients could receive additional cycles at the discretion of the treating physician and patient. All patients received folic acid, vitamin B12, and dexamethasone prophylaxis. Results: Eighty patients (53 men and 27 women) were enrolled in this study with assigned informed consent form. The median age was 53 years. 88% had a performance status of 1. 51 patients were received 4 cycles. 501 ADRs were recorded in chemotherapy cycles of pemetrexed-carboplatin. From 501 ADRs the non-hematological ADRs were 116 and hematological ADRs were 385. There was Grade 3 hyponatremia in 6 patients, Grade 3 anemia in 3 patients, Grade 3 neutropenia in 1 patient, respectively. Nine patients experienced Grade 3 nonhematologic side effects (diarrhea, constipation, cough, dyspnea, hypersensitivity reaction). Only 1 patient had alopecia Grade 2. Conclusion: The present study has captured and assessed ADRs in Indian patients which can assist the multidisciplinary team in cancer hospital to design educational modules and Standard Operating Procedures for preventive medications and help to design the future risk management strategies associated to pemetrexed-carboplatin, chemotherapies in Non-small cell lung cancer
| » CPP-13: Cost Analysis of Antimicrobial Therapy in Elderly Hypertensive Diabetic in-patients in a Tertiary Care Hospital | | |
Bhandary A, Bhandari PR, Sherkhane RM
Department of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India
E-mail: [email protected]
Background: One of the many reasons why patients go off-regimen is due to the cost of the drugs which could be cut down by prescribing a cheaper effective brand. Objective: Prescription pattern of antimicrobials in elderly hypertensive and diabetic in-patients. To analyse the cost variation in different brands of commonly used antimicrobials in elderly hypertensive and diabetic in-patients. Methods: The study population consisted of 117 elderly hypertensive diabetic in-patients on anti-microbial agents at Shri Dharmasthala Manjunatheshwara (SDM) Hospital. Questionnaire-based study was conducted. The same strength of antimicrobial agents manufactured by various pharmaceutical companies were studied. Their maximum prescribed cost and minimum available cost was in rupees (INR) was noted. The percentage cost variation and cost index were calculated. Results: A total of 230 antimicrobial agents were prescribed among which 88 were fixed dose combinations (FDCs). Anatomical therapeutic classification (ATC) class J01D – other β lactam antibacterials was most commonly prescribed antimicrobial class 40.85% (n=58) of which ceftriaxone was used most frequently (35.21%) and ATC class J01CR (combination of penicillins inclusive of β lactamase inhibitors) was most commonly used class aong FDCs, 47.7% (n=42). The maximum cost index (13.14) and percentage cost variation (1213.51) was seen with injection azithromycin 500mg. Conclusion: Our study proves that there was a significant cost variation in different brands of same generic antimicrobial agent. Thus, physicians need to take into consideration the cost burden to the patient while prescribing that will help improve patient compliance.
| » CPP-14: A Study on Evaluation of Drug Prescribing in Patients of Hypertension in Medical Care Hospital | | |
Suthar JV, Shah P, Patel K, Pathak P
Department of Pharmacy, Ramanbhai Patel College of Pharmacy, Charusat University of Science and Technology, Anand, Gujarat, India
E-mail: [email protected]
Objective: The objective of this research was to evaluate prescribing pattern of antihypertensive drugs in Patients at Private Hospital. Methods: A Prospective Observational study was carried out for one month duration in the General Medicine department of Kunal Medical Hospital, Ahmedabad, Gujarat. Descriptive analysis of collected information was done which involved representation of demographical data, number of comorbidities, number of drugs prescribed, and type of FDCs accordingly. Results: During study, 100 cases of hypertension were observed. Among which 55% were males and 45% were females attended the hospital. Six different classes of anti - hypertensive drugs were used in the prescription. They were Diuretics (Ds), Calcium Channel Blockers (CCBs), Angiotensin Receptor Blockers (ARBs), Beta Adrenergic Blockers (BABs), Alpha Adrenergic Blockers (AABs) and Angiotensin Converting Enzyme Inhibitors (ACEIs). Angiotensin Receptor Blockers were used the highest in 31 prescriptions and AABs in 4 prescriptions being the least. Conclusion: Diuretics class of antihypertensive- Furosemide was the most frequently utilized drug (30.95%) and Ramipril (1.36%) of Angiotensin Converting Enzyme Inhibitors class of drug was the least prescribed drug. Combination therapy and FDCs were also prescribed in patients.
| » CPP-15: Aceclofenac - Induced Toxic Epidermal Necrolysis: A Case Report | | |
Latha S, Jyothi CH
Department of Pharmacology, JJM Medical College, Davangere, Karnataka, India
E-mail: [email protected]
Objective: Report a case of Aceclofenac induced Toxic epidermal necrolysis (TEN) to emphasize the need for effective pharmacovigilance. Methodology: Case report – 65yr old male patient presented with history of erythema with evolving rash & burning sensation all over the body after consuming tab aceclofenac 100mg, which was prescribed the previous evening for history of self fall & pain in the left hip. On examination, Multiple erythematous skin lesions were present over chest, abdomen, back, bilateral upper & lower extremities (>30%). Which were progressive, with new lesions & finally generalized macules, papules, vesicles & bullae were formed in 2 days. Later, there was generalized rupture of flaccid bullae & detachment of epidermal skin layer. Patient was admitted in ICU, Aceclofenac was withdrawn & the case was reported to the pharmacovigilance center of the Institute, photographs were taken. Betamethasone i.v, was given for 3 days later switched to tablets and tapered. Skin lesions were treated symptomatically with gentian violet & fusidic acid with Supportive measures. NSAIDs were replaced with tramadol. Vitals was monitored. Patient recovered in 10 days and was discharged. Conclusion: TEN is fatal dermatological condition with complex pathology, with relatively low incidence & with significant morbidity and mortality. Aceclofenac is most commonly used analgesic, hence reporting of such adverse events through effective pharmacovigilance is utmost important.
Keywords: Aceclofenac, adverse drug reactions, pharmacovigilance, TEN
| » CPP-16: Pattern of Adverse Drug Reactions over a Period of 6 Months in a Tertiary Care Hospital | | |
Keshwala AR, Trivedi HR
Department of Pharmacology, M. P. Shah Government Medical College, Jamnagar, Gujarat, India
E-mail: [email protected]
Objectives: To study and analyse the various adverse reactions occurring in a tertiary care hospital, Jamnagar. Methods: A prospective, observational study was carried out for duration of 6 months (Sep 2016-February 2016). Necessary data regarding adverse drug reaction and relevant treatment were collected from various department in a tertiary care hospital. ADR reporting forms issued by CDSCO were used to record the ADRs. Causality, severity and preventability were assessed by WHO causality assessment scale, Hartwig and seigels scale & Shumock and Thornton scale respectively. All ADRs were uploaded and reported for central assessment in vigiflow. Results: Total 118 ADRs were during this period. Out of 118 patients 53 were females (45%) and 65(55%) were males. The most commonly affected system was gastrointestinal system 37.28%, followed by blood 23.72%. Anti microbial agents 44.91%, Pyrizinamide 10.16% and Rifampicin 9.32% were most common Antimicrobial agents responsible for ADRs. According to WHO causality assessment most of the ADRs were “possible” 74.57%, followed by “probable” 23.72% and By Hartwig and seigels scale ADR were “mild adrs” 46.61%, “moderate adrs” 30.50%, “severe adrs” 22.88% & Shumock and Thornton scale shows 99.15% were “not preventable” and 0.85% was “preventable”. Conclusion: Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects.
| » CPP-17: A Prospective Study on Prescribing Pattern of Antiasthmatic Drugs in Adult in a Tertiary Care Hospital | | |
Batar KK, Swami NK, Gehlot A
Department of Pharmacology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India
E-mail: [email protected]
Objective: This study was carried to evaluate the pattern of use of antiasthmatic drugs, adverse drug reactions and utilization pattern of these drugs in adults. Methods: This study was conducted in collaboration with department of Medicine for a duration of 2 months. After approval from the Institutional Ethics Committee, eligible participants were approached and requested to give a voluntary consent to participate in this study. A survey was done asking structured questionnaire, these questionnaire were based on symptoms, medication, family history, occupation etc. Out of 240 patients, 120 patients were prescribed MDI Salbutamol (SABA), as there was no night waking in them, 97 patients were prescribed MDI Beclomethasone (regular low dose ICS plus as-needed SABA) and 23 patients were presented with severe asthma prescribed nebulization with Ipratropium (every 8 hourly) plus Formoterol (every 12 hourly) plus Budesonide (every 12 hourly) respectively. The all relevant details of the drugs prescribed, related ADRs were noted and analysed using SPSS 17.0. Results: Of the 240 asthma patients; 50%(120) were using MDI Salbutamol, 40.4%(97) were using MDI Beclomethasone and 9.6%(23) were using Nebulization with Ipratropium, Formoterol and Budesonide respectively. Results of our study have shown a good prescribing pattern of antiasthmatic agents, included only few ADRs (12%). Conclusion: In Government hospital set up the treatment guidelines are followed as per patients condition, availability of drugs etc. In asthmatic patients if medication is followed as per GINA guidelines, it becomes a smooth control of the symptoms along with lesser recurrenes and ADRs. In our study, also treatment guidelines were followed correctly and patients had a good follow up.
| » CPP-18: Pantoprazole-domperidone Combination Induced Flushing: A Case Report | | |
Smriti, Srivastava B, Agrawal P, Khanchandani R, Gaur S
Department of Pharmacology, Government Medical College, Haldwani, Uttarakhand, India
E-mail: [email protected]
Objective: To do the causality assessment of the ADR i.e flushing, due to oral pantoprazole domperidone combination. Methods/Case Report: 48 years old male was prescribed oral pantoprazole domperidon combination prophylactically for gastritis along with other drugs for back pain Immediately after taking medicine there was flushing and itching all over the body. Results: Drug was withdrawn and no patch test was done. No relapse mentioned. Case was uploaded in vigiflow and was reported to pvpi causality is probable as the reaction started suddenly after taking the drug. When the drug was withdrawn no recurrence was seen. rechallenge was not required. Conclusion: flushing due to oral combination is rare. The reaction of oral drug is least reported and this combination should be taken seriously along with other drugs.the ADR should be reported to the national co-ordination centre for judicious and safe use of medicine/ drugs.
Keywords: Causality, flushing, itching, pantoprazole-domperidone combination, vigiflow
| » CPP-19: Age and Gender Related Differences in Pattern of Adverse Drug Reactions: A Retrospective Observational Study at a Tertiary Care Hospital | | |
Kavyashree AC, Jayanthi CR, Laxminarayana Kamath
Department of Pharmacology, Bangalore Medical College and Research Institute, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
E-mail: [email protected]
Objective: The female gender and elderly population appears to suffer more from adverse drug reactions (ADRs). This study was undertaken to examine age and gender related ADR patterns among patients and to assess their causality, predictability, severity and preventability. Methods: This observational study was carried out to analyze the ADRs reported spontaneously from October 2016 to Nov 2017 at Hospitals attached to BMCRI to the ADR monitoring centre. Patient demographics, clinical and drug data, details of ADR, onset time, causal drug details, outcome and severity were collected as per CDSCO-ADR reporting form. Causality was assessed using WHO-ADR probability scale, Preventability by Modified Schumock & Thornton scale and Severity by Hartwig & Siegel Scale. Results: Total of 232 ADRs were reported in the last 1 year. Majority of the ADRs (68%) were observed in 18-59 years of age group. Incidence of ADRs in males and females was 47% and 53% respectively. 62.5% of the ADRs were of 'probable' causality and 62% were predictable ADRs. Severity assessment indicated 52% as moderate and 6% as severe ADRs (6+7). Among those ADRs 44% were preventable. 61% of the ADRs required additional medical treatment and causative drug was withdrawn in 49%. Conclusions: A slight female preponderance was observed and adults were more commonly affected. Majority of the ADRs were moderate and predictable. Hence there is a need for strategies for prevention, early recognition and proper management of ADRs.
Keywords: Adverse drug reactions, causality, predictability, preventability, severity
| » CPP-20: Carbamazepine Induced Stevens Johnson Syndrome (sjs) in Patients Suffering from Epilepsy and Trigeminal Neuralgia | | |
Bitinti Srilatha1,2, Vijaya Bhaskar Reddy Y1,2, Sharon Sonia S1,2
1Department of Pharmacology, Kurnool Medical College, Kurnool, 2Dr. NTR University of Health Sciences, Vijayawada, Andhra Pradesh, India
E-mail: [email protected]
Introduction: Adverse drug reaction (ADR) is a noxious and unintended response at doses normally used or tested in humans.SJS is a rare auto-immune disorder which mainly includes skin and mucous membrane, with an incidence of 0.05 to 2 per million per year and mortality of 3-10%. Case Report: Case 1: A 42 years old male patient developed epileptic fits, he has taken carbamazepine. After 3 days patient developed rashes, followed by erosions all over the body, and associated with mild fever and malaise, oral genital crustations present. It was diagnosed as SJS, by Dermatology department, GGH, Kurnool. The drug was stopped and the patient was treated with prednisolone, chlorpheniramine, pantoprazole and soframycin ointment. Case 2: A 40 years old female patient has taken carbamazepine for trigeminal neuralgia. After 6 days patient developed skin rashes all over the body, later she developed black coloured spots all over the body and edema. The diagnosis of SJS was made. Carbamazepine was withdrawn and treated with dexamethosone, cetrizine and benzocaine gel, pantaprazole. In both the above cases dechallenge test was positive. Recovery followed the treatment. Rechallenge was not done. So they are classified as “probable” as per UMC Causality Assessment Scale. Discussion: SJS is a delayed hypersensitivity inflammatory reaction, which is mainly caused by drugs like sulfonamides and antibiotics. The recent studies have reported SJS caused by NSAIDS, anti-convulsants, and antiretroviral drugs. From these cases it was also found that Carbamazepine can cause SJS. Conclusion: ADRs are one of the important causes of hospitalization in recent times. A robust ADR monitoring system with a feedback to and the education of the prescribers Can prevent, identify and manage this life threatening condition.
| » CPP-21: Prescription Pattern and Rationality of Antihypertensive Drugs in Patients of Type 2 Diabetes with Hypertension | | |
Khandare K, Bhore AS
Department of Pharmacology, Dr. Panjabrao Deshmukh Memorial Medical College, Amravati, Maharashtra, India
E-mail: [email protected]
Objectives: To study current prescribing pattern of antihypertensives in patients of diabetes and assess the rationality to recommendations of JNC-8 guidelines. Methods: We performed a cross sectional survey of prescription of diagnosed patients of diabetes with HTN at a tertiary care hospital. Prescription of patients attending medicine OPD were scanned. Data was collected over 1 month and analysed with descriptive statistics. Results: In 76 patients analysed, mean age was 54.9±9.3 years and 51.3% were females. Insulin and oral antidiabetic agents were prescribed in 16 (21.1%) and 73 (96.1%) patients respectively. One, two, three and four antihypertensive drugs were prescribed in 44 (57.9%), 28 (36.8%), 3 (3.9%) and 1 (1.3%) patients respectively and 24 (31.6%) of them were fixed dose combinations. Among antihypertensives, angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), diuretics, beta blockers (BBs) and calcium channel blockers (CCBs) were present in 29 (38.2%), 26 (34.2%), 22 (28.9%), 21 (27.6%) and 14 (18.4%) respectively. In individual drugs, ramipril (22, 28.9%) was most common followed by telmisartan (20, 26.3%), hydrochlorothiazide (20, 26.3%), atenolol (16, 21.1%) and amlodipine (13, 17.1%) were frequently prescribed. In adjuvant drugs, antiplatelet (40, 52.6%) and statins (43, 56.6%) were common. Aspirin was prescribed in all cases. Atorvastatin was most common (39, 51.3%) statin prescribed. This pattern of prescription was as per the recommendations of recent JNC-8 guidelines for treatment of hypertension. Conclusion: ACEIs/ARB are most preferred for HTN treatment in diabetes. Prescription of antihypertensives in our set up was rational as per JNC-8 recommendation.
| » CPP-22: Awareness of Pharmacovigilance Programme of India among Second Year Nursing Students in a Southern Teaching Tertiary Care Institution | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the awareness of Pharmacovigilance Programme of India among second year nursing students in a southern teaching tertiary care institution. Methods: This study was done over a period of one year in a nursing teaching tertiary care centre. The study protocol was approved by the institutional review board. Indian ICMR ethics guidelines for human biomedical research were followed. Prevalidated questionnaire forms covering different domains of Pharmacovigilance Programme of India [PvPI] were distributed to the second year nursing students. The completed forms were taken for final data analysis. Data was represented as descriptive statistics. Results: In this study total of sixty nine participants were enrolled after obtaining written consent from them. Most of the questions related to the knowledge domain of PvPI were not answered correct by the study participants and the overall correct response rate was below 50%. It was also seen that, only less than 1/4th of the study participants were trained in clinical principles of PvPI including on how to report ADRs. Domain pertaining to the practices, it was revealed that, only less than 15% of study participants had reported ADRs during their professional time. It was opined by most of the study participants that, the best way to improve the ADR reporting in PvPI, was to make more awareness among public including lecture series on this arena. Conclusion: This study showed that, there was a poor knowledge with poor practices but with positive attitude towards the Pharmacovigilance Programme of India among second year nursing students in a Southern teaching tertiary care institution.
[TAG:2]CPP-23: Existence of Principles of Research among Dental Interns: A Cross-sectional Survey [/TAG:2]
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the existence of principles of research among dental interns in a Southern based teaching tertiary centre and hospital. Methods: This study was carried out in a Southern based teaching tertiary care centre and hospital with dental interns as study target population. Initially the questionnaire related to biomedical research principles were prepared with consultation of subject experts in this area and prevalidated on few numbers of voluntary participants. After prevalidation of questionnaire, it was distributed among target population. Data from the questionnaire forms were recorded and represented as frequency and percentage. The study protocol was approved both by the Institutional Scientific Advisory Committee [ISAC] and Institutional Human Ethics Committee [IHEC]. A prior well written informed consent was taken from all the study participants before their recruitment into the study. Results: In this study a total of thirty nine participants were enrolled and their data was taken for final data analysis. All the study participants answered the correct responses to the questions related to the biomedical research principles with the correct response rate of less than 40% only. However interestingly it was seen that, more than 83% of study population were willing to undergo training on biomedical research in the form of lecture series/seminars/workshops to enhance their knowledge in this area. At the same time, this study also showed that, practices towards the biomedical research principles was not upto the mark with only less than 10% of study participants were confidant of designing the study of their own to carry out the research project. Conclusion: This study shown that, there was a poor knowledge and unsatisfactory practices but with positive attitude towards the principles of research among dental interns in a Southern based teaching tertiary centre and hospital.
| » CPP-24: Questionnaire Based Feedback Survey on Adr Monitoring among Undergraduate Trainees of Nursing Students from Teaching Hospital of Southern India | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the feedback survey on ADR monitoring among undergraduate trainees of nursing students from a teaching hospital of Southern India. Methods: A cross-sectional study was done involving the undergraduate trainees of nursing students from a teaching hospital of Southern India over a period of one year. Questionnaire forms related to the Pharmacovigilance was distributed to the study target population and were asked to return back after its complete filling. The obtained data was expressed in number and percentage. Biomedical research ethics principles were adhered throughout the study period. Results: Study findings include, questions pertaining to the knowledge domain of ADR monitoring was not answered correct by the study participants [more than 60%], however there was a positive attitude towards the ADR monitoring with more than 87% of participants opined to have training in this filed in the form of continuous lecture series/workshops/symposia/seminar or other educational activities. It was also found that, only less than 14% of study participants were reported ADRs. Other findings in the study include various combinations of methods, was suggested as a good approach for further better improvement in the ADR reporting system and the lack of time was the most discouraging factor for poor reporting of ADRs to the monitoring centers. Conclusion: This study revealed, there was a poor knowledge with unsatisfactory practices towards the ADR monitoring among undergraduate trainees of nursing students from a teaching hospital of Southern India. Interestingly it was also observed that, there was a positive attitude towards the ADR monitoring among undergraduate trainees of nursing students from a teaching hospital of Southern India, which can be improved by encouraging through various educational CME/symposia programmes with better institutionalized policies.
| » CPP-25: An Observational Analysis of Adherence to Biomedical Research Ethics Principles among Nursing Faculty of Southern Teaching Institution | | |
Madhavrao C, Mythili Bai K, Sharath Babu K1, Prathab Asir A1
Department of Pharmacology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, 1Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
E-mail: [email protected]
Objectives: To study the adherence to biomedical research ethics principles among nursing faculty of southern teaching institution. Methods: The adherence to the basic biomedical research ethics principles among nursing faculty of southern teaching institution was studied through questionnaire based feedback survey after getting approval from the Institutional Review Board [IRB]. A written informed consent was obtained from the study population. The privacy and data confidentiality of study participants was maintained as per the ICMR bioethics guidelines, New Delhi {2006}. The descriptive statistics was used for the data representation. Results: This study had a total of thirty one nursing faculty from different disciplines of nursing academy. It was revealed that, more than 63% of study participants gave correct responses to all the questions related to the knowledge on biomedical research ethics principles. Still many of the study participants willing to undergo some kind of teaching and learning educational trainings to update their knowledge in biomedical research ethics principles for further strengthening their skills in research activities. The study also revealed that, many [>87%] had experience in carrying out some kind of basic research in their own speciality or involved as co-investigator. Again most of the study participants had good experience and exposure in presenting their research work in various conferences/symposia. Conclusion: There was a good knowledge and good practice with positive attitude towards the biomedical research ethics principles among nursing faculty of a southern teaching institution.
| » CPP-26: Comparative Assessment of the Efficacy and Safety of Sertaconazole (2%) Cream versus Luliconazole (1%) Cream in Patients with Dermatophytoses: A Prospective, Randomized, Open Label, Parallel Study | | |
Dakhale Ganesh, Mukhi Jayesh, Gupta Aashish1, Kalikar Mrunalini
Department of Pharmacology, GMC, 1Department of Dermato-Venereo-Leprology, GMC, Nagpur, Maharashtra, India
E-mail: [email protected]
Objective: To compare efficacy and safety of sertaconazole and luliconazole cream in patients with dermatophytoses.Methods: A prospective,randomized,open-label, parallel study initiated after approval of the institutional ethics committee in 64 patients of tinea corporis and tinea cruris infection attending the OPD of dermatology department in tertiary care teaching hospital. The initial 'Treatment Phase' involved two groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks and luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a follow up phase, where efficacy was assessed clinically using 4-point physician global assessment (PGA) scale and mycologically by KOH mount.Safety was assessed by monitoring adverse drug events at each visit. Results: Out of 64 patients, 59 completed the study, sertaconazole (n=30), and luliconazole (n=29).The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in both groups, at the end of treatment and follow-up phases. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in both the groups. The PGA scale showed successful treatment outcome (clinical cure + mycologically negative) in sertaconzole group as compared to luliconazole group.Both groups showed equal negative mycological assessment without any relapses.Both study drugs were well tolerated. Conclusion: Sertaconazole was better than luliconazole in relieving signs & symptoms during study and follow up period. At the end of treatment Phase and follow-up phase,all patients showed negative mycological assessment in both treatment groups suggesting no recurrence of the disease.
| » CPP-27: Study of Effectiveness, Safety and Tolerability of Aceclofenac, Diclofenac and Paracetamol in Osteoarthritis | | |
Sareetha AV, Nagabushan H, Manjappa CN
Department of Pharmacology, Mandya Institute of Medical Sciences, Mandya, Rajiv Gandhi University, Karnataka, India
E-mail: [email protected]
Objectives: To evaluate the effectiveness of Aceclofenac, Diclofenac and Paracetamol in osteoarthritis. To assess the safety and tolerability of Aceclofenac compared to Diclofenac and Paracetamol. Materials and Methods: A prospective, randomized, study carried out among 240 osteoarthritis patients. The subjects were randomized 1:1:1 into 3 groups, 80 in each, to receive Aceclofenac, Diclofenac and Paracetamol for 6 weeks. Visual analogue score (VAS) and WOMAC score were used to assess the effectiveness. Safety and tolerability were assessed by laboratory testing and adverse drug events respectively, and the overall assessment by Likert scale. Results: A total of 240 patients were analysed. There were 127 (52.9%) males and 113 (47.1%) females with mean age of 56.98±8.07. There was a significant (p <0.001) decrease in VAS score in Aceclofenac (53.25 ± 13.85 to 10.38 ± 10.49), Diclofenac (57.00 ± 14.27 to 9.00 ± 10.98) and Paracetamol groups (58.50 ± 13.42 to 10.53 ± 6.69), while the decrease in mean WOMAC score in all domains of Aceclofenac and Diclofenac groups was more than that in Paracetamol group (p <0.001). The overall response in Aceclofenac (53%) and Diclofenac (53%) treated groups was equal with a score of 4 by Likert scale. Aceclofenac and Paracetamol were safer and better tolerable than Diclofenac. Conclusion: Aceclofenac is effective, safer and has better tolerability profile. Hence Aceclofenac can safely replace Diclofenac as an NSAID of choice in osteoarthritis.
Keywords: Aceclofenac, diclofenac, likert scale, osteoarthritis, paracetamol, VAS, WOMAC
| » CPP-28: Antimicrobial Prophylaxis of Surgical Site Infection in a Tertiary Care Hospital – A Descriptive Study | | |
Halasawadekar NR, Murthy MB, Jadhav PG, Ramanand SJ, Burute SR, Salunke AT
Department of Pharmacology, GMC, Miraj, Maharashtra, India
Objectives: To find out frequency of antimicrobial prophylaxis in patients undergoing surgery. To find out frequency of antimicrobial use in postsurgical patients. Methodology: It is prospective analytical study conducted in tertiary care hospital. Inclusion criteria- patients being posted for major surgeries in departments of general surgery, obstetrics and gynaecology. Exclusion criteria- patients posted for emergency surgeries (except LSCS). Results: Total of 78 cases were included. Chemoprophylaxis was received by 76 patients (97.4%). The type of surgery, number of patients and frequency of antibiotic use is - emergency LSCS - 56 (71.79%), out of which 43 (76.78%) patients received aminoglycosides & third generation cephalosporin presurgically. Hernioplasty- 09 (11.53%), 04 (44.44%) patients received first generation cephalosporin . Incisional hernia-04 (5.12%), 02 (50%) patients received first generation cephalosporin. Elective LSCS- 03 (3.84%), all patients received third generation cephalosporin and aminoglycosides. The details of postsurgical continued use (no and days) of antimicrobials is - emergency LSCS - all patients with mean duration of 3.85 ± 1.5. Hernioplasty- 07 (77.7%) patients with mean duration of 4.75 ± 1.669 days. Incisional hernia repair- all patients with mean duration of 4.8 ± 1.09. Elective LSCS- all patients with mean duration of 3.75 ± 0.5. Conclusion: Antimicrobial prophylaxis was given in almost all clean cut surgeries. Most common antimicrobial used were aminoglycosides and third generation cephalosporines. Antimicrobials were continued postsurgically.
| » CPP-29: Epidemiological study of β-casein alleles on human health | | |
Yadav SK1, Radhakrishnan M1, Saxena V2, Garg S2,1
Departments of 1Pharmacy and 2Biological Sciences, BITS, Pilani, Rajasthan, India
Objectives: To study the health status of the family consuming milk from cattle having A1A1, A1A2, A2A2 genotype in desi and Holstein Friesian breeds. Introduction: The most common variants of beta-casein genes are A1 and A2 in dairy cattle. The A2 β-casein gene is recognized as the progenitor of β-casein gene in the genus Bos. A2 allele differs from A1 by the presence of a Proline at position 67 instead of Histidine in A1.The presence of Histidine allows enzymatic hydrolysis to generate a seven amino acid peptide known as beta-casomorphin 7. The peptide is biologically active and involved in elicitation of various diseases such as diabetes, oral tolerance, etc. Methods: Genotype of cattle was identified by isolating their DNA and sequencing exon 7 of beta-casein encoding gene. All farmer families were categorized in three groups viz A1A1, A1A2, A2A2, based on the genotype of their cows whose milk they were consuming. Study was done within 100Km area across Pilani town, Jhunjhunu, Rajasthan. Data was collected by considering similar socioeconomic condition of all the families to eliminate any variation due to nutritional or hygiene effects. Questionnaire was prepared based on type of milk consumption (genotype of cattle) and health status of family members. Main diseases included oral tolerance, regularity of biological cycle, menopause, arthritis, diabetes and general immunity. Data obtained were analysed using one-way Analysis of Variance (ANOVA) followed by post test Tukey's using GraphPad Prism, version 7.00 (San Diego, CA, USA). Data obtained were considered as statistically significant if p < 0.05. Results: In A1A1 families children had significantly high oral tolerance, female observed irregular biological and early onset of menopause in comparison to A1A2 or A2A2 families. Higher proportion of arthritis, diabetes and low general immunity was also observed in A1A1 families. A1A2 families show more inclination towards disease susceptibility compared to A2A2 families. Families consuming milk from desi cows or A2A2 genotype cattle were healthy as far as these diseases, are concerned. Conclusion: Milk obtained from A2A2 HF or Indian Zebu cattle (mostly A2A2) was supposed to be better for human health, based on the study.
| » CPP-30: Drug Utilizat Ion Pattern and Pharmacovigilance Study of Anti-diabetic Medications in GMC and H: A Tertiary Care Hospital Based Study | | |
Gurram S, Sharma D, Lahkar M, Lihite RJ
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research-Guwahati, Assam, India
E-mail: [email protected]
Objective: This study was designed to evaluate the prescription pattern of ant-diabetic drugs in diabetes patients and to monitor the adverse drug reactions related to anti-diabetic therapy. Methods: This was a prospective observational study carried out over a period of six months in the outpatient department of Endocrinology of Gauhati Medical College and Hospital (GMC&H). The study was approved by the Institutional Ethics Committee. Results: During the study period, a total of 314 known diabetic patients were evaluated. Of 314 patients, 307(97.7%) were type2 DM and remaining 7(2.2%) were type1 DM. 186(59.2%) were males and 128(40.7%) were females. Most of the patients were in the age group of 40-59years (n=220, 70.0%). Co-morbidities were found in 171 patients (54.4%). The most common co-morbid condition was hypertension (n=97, 56.7%). Insulin was the most commonly prescribed dug (n=172, 72.5%) as monotherapy followed by metformin (n=58, 24.4%). 69(21.9%) patients were reported with an incidence of ADRs out of which 46(66.7%) were males and 23(33.3%) were females. Maximum number of ADRs were reported in the age group of 50-59 years (n=24, 34.8%). The most commonly occurring ADRs were hypoglycemia (n=48, 69.5%) followed by diarrhoea (n=16, 23.1%). Conclusion: Insulin and metformin were the most commonly prescribed anti-diabetics. Our study has concluded that the choice of anti-diabetic drugs was only slightly changed compared to the previous study. The average number of drugs per prescription was 3.6±0.69 and the average number of anti-diabetic drugs giver per prescription was 1.26±0.48. Commonly reported ADRs were hypoglycemia followed by diarrhoea.
| » CPP-31: Statin Therapy: Risk Assessment, Dosing and Patient Adherence | | |
Umarje SP, Raut AL, James NM, Dave PA1
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, 1Department of General Medicine, Bharati Hospital and Research Center, Pune, Maharashtra, India
E-mail: [email protected]
Aim: To conduct atherosclerotic cardiovascular risk assessment, assess the choice of statin, patient adherence and lipid reduction. Materials and Methods: A prospective cross-sectional study was conducted at a tertiary care hospital in the Department of Medicine on 375 patients (>21 years). The patients were assessed for lifestyle parameters and prevalence of diabetes, hypertension, dyslipidemia and atherosclerotic disorders. The '2013 American College of Cardiology/American Heart Association guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults' was used as a standard reference for assessing the dosing of statin therapy. 'Pooled Cohort Equation' was used to calculate the 10-year risk in primary prevention patients. Systematically developed interview questionnaire was used for assessing the adherence. Results: An elevated risk was observed in 46.08% and 69.33% were having one or more atherosclerotic diseases; out of which 58.46% had cardiovascular disorders. The age group 61 to 80 years was found to be the high risk age group in both genders. Diabetes, hypertension, smoking/ tobacco, improper diet and sedentary lifestyle had a statistically significant association (p-value <0.05) whereas dyslipidemia had a statistically non-significant association (p-value >0.05). Statin utilization was reported in 90.93% of total study population out of which 82.99% use was with atorvastatin (p-value <0.001). Deviation of statin use from standard recommendations was more in primary prevention patients. Adverse effects were observed in 28.44% of patients wherein myopathy (60%), transaminitis, (25.45%) and sleep disturbances (14.54%) were commonly observed. Rosuvastatin was significantly association with the adverse effects (p-value 0.00062). Adherence and knowledge had an inverted U shaped association. Good adherence was statistically significant in patients with cardiovascular disorders (p<0.005) and lipid reduction had a direct association with the type adherence. Conclusion: Prevalence of atherosclerotic cardiovascular diseases is high and men are at a higher risk at a younger age. Diabetes, hypertension, smoking, improper diet and sedentary lifestyle are associated with atherosclerotic diseases. Factors such as cost, effectiveness and available marketed formulations have a direct impact on statin utilization. Use of risk assessment tools may promote rational statin use. Knowledge, chronicity of therapy and clinical condition affect the adherence. Lipid reduction can be obtained by good adherence to statin therapy.
Keywords: Adherence, adverse effects, deviation, prevalence, utilization
| » CPP-32: Antimicrobial Resistance: A Ticking Timer in a Nutshell | | |
Augustine SS, Prabhakar B
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To provide insight about the potentiation of antimicrobial resistance in humans through consumption of livestock and farm products. Introduction: In this era of urbanisation and rapid technological development, antimicrobial resistance is passively emerging as a major threat to public health. Despite having restrictions for use, antimicrobials have been extensively used by humans as well as in animals in farming industry. Consumption of anti-microbials directly by humans has indeed seeded resistance in the consumers at large but it has also been influenced indirectly by consumption of livestock and agricultural products that have been spiked with anti-microbials at farms. This article provides information on the history and development of anti-microbials and its scenario in the 21st century. Anti-microbials have been used in livestock as growth promoters along with vitamin B12. It gives the effect of antimicrobials on the food chain and how the potentiation of anti-microbial resistance takes place due to consumption of livestock. It also gives the statistics related to antimicrobial resistance and the probable future scenario. It discusses the measures taken by the regulatory bodies around the world like U.S. food and drug administration, MHRA, TGA etc. to minimise the risk associated with anti-microbial resistance. Conclusion: Through this presentation, we intend to disseminate information related to various aspects of anti-microbial resistance and the possible measures to reduce the associated risks.
| » CPP-33: Intragastric Balloon for Obesity – Is It a Boon or Bane? | | |
Rathod VH, Shetty SR
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India
E-mail: [email protected]
Obesity is a complex metabolite disorder that results from surplus accumulation of body fat and may lead to undesirable health concerns. It has grasped new prevalent levels in the world. As per WHO reports, in the year 2016, more than 1.9 billion adults, 18 years and older, were overweight. Of these over 650 million were obese. 41 million children under the age of 5 were overweight or obese and over 340 million children and adolescents aged 5-19 were overweight or obese. Hence, utmost need of minimally invasive and effective methods for treating obesity is desired. In this review, a swallowable gastric balloon is discussed with its effectiveness and challenges. It provides a brief summary of the intragastric system which is a balloon made of soft silicone inserted through the oesophagus and placed in the stomach with no incisions, no scars and no surgery. It is a capsule which is attached to a micro-catheter and by using x-ray the capsule can be safely placed in the stomach. The balloons can be placed for six months for treatment efficacy. These balloons can be used for various treatment as a pre-emptive therapy, a metabolic therapy, or a primary therapy. Different type of balloons as per FDA approved will be highlighted with their complications and challenges. Through this presentation, we intend to disseminate concise information on controlling obesity which has become a major epidemic nowadays.
| » CPP-34: Study of Efficacy and Safety of Second Line Art Regimen in HIV/AIDS Patients in a Tertiary Care Centre | | |
Desai S, Dass PA
Department of Pharmacology, Gulbarga Institute of Medical Sciences, Gulbarga, Karnataka, India
E-mail: [email protected]
Objective: To assess the efficacy and safety of second line ARV drugs (tenofovir 300mg + lamivudine 300mg + atazanavir 300mg and ritonavir 100mg) by CD4 count and plasma viral load. Methods: This was a longitudinal, prospective, observational study carried out in HIV positive patients attending ART centre, government general hospital, Vijayawada. Patients receiving first-line ARV drugs for at least six months were evaluated clinically, immunologically (CD4 count) and virologically (plasma viral load) for failure and started on second-line ART. A total of 100 patients were included and followed up for a period of 12months. Results: Out of 100 patients, 52 patients developed ADRs. In this 52, 34 patients had CD4+ count <250 cells/cu.mm and the remaining 18patients had CD4+ count >250 cells/cu.mm. The observed difference was statistically significant (p<0.0001). The plasma viral load after six months of therapy were decreased compared to the initial mean values. The increase in CD4 count and haemoglobin and decrease in plasma viral load were extremely statistically significant (P < 0.0001). Conclusion: The ADRs were most common in those patients whose CD4+ count is <250 cells/cu.mm. Early treatment outcome with second line ART in terms of immunological improvement and viral suppression was good in treatment experienced patients. Though atazanavir containing regimen is more efficacious but produces more serious adverse effects.
Keywords: AIDS, ARV, CD4 count, plasma viral load
| » CPP-35: Assessment of Perception and Attitude of Postgraduates and Clinicians towards Generic versus Branded Medicines at a Teaching Medical Institute | | |
Desai S, Dass PA
Department of Pharmacology, Gulbarga Institute of Medical Sciences, Gulbarga, Karnataka, India
E-mail: [email protected]
Objective: To assess the attitude of clinicians and post graduate students regarding generic drugs and branded drugs. Methods: The present study was a cross-sectional study .A pretested questionnaire was distributed to the clinicians and post graduate students at NRIMC and SMC,Vijayawada. Assurance of confidentiality (Informed Consent) was also taken from the participants. After approval and clearance from the Institutional Ethics Committee, 75 participants were included in the study. After explaining about the nature and purpose of the study, the study subjects were interviewed by using structured questionnaire, to assess the awareness about the generic drugs and to determine the attitude and practice towards generic drugs. Analysis was performed and the data were expressed in n (%). Results: In the present study, 87.7% of clinicians and postgraduates were aware of generic drugs. Most doctors believed that generics r therapeutically (59.6%) and safety wise (71.9%) equivalent to branded drugs 89.5% are of the opinion that generics are cheaper than branded ones. 59.6% of them were aware of Jan Aushadi pharmacy. Conclusion: A very good percentage of doctors were aware of generic medicines their attitude towards safety, efficacy and cost effectiveness of generic medicines was good and majority of them said that they prescribe generic drugs. But there was a meaningful proportion who expressed their concern about quality and efficacy of generic drugs. These beliefs could hinder larger generic drug use and increase health-care expenses of patients with chronic illness. Proper awareness in physicians about the generic prescription practice may improve the patient compliance by reducing the economic burden to the patients.
Keywords: Attitude, brand drugs, generic drugs, jan aushadhi, practice
| » CPP-36: Satisfaction Outcomes of Randomized Phase III Clinical Trial Participants: A Prospective Study Analysis | | |
Parloop Bhatt, Keyur Parikh1
LM College of Pharmacy, 1CIMS Hospital, Ahmedabad, Gujarat, India
Background: In developing nations economic expedient more than human welfare is the belief to conduct clinical trials. A first of its kind clinical trial subject satisfaction and risk-benefit questionnaire was developed and prospectively studied in India. Methods: Total of 294 clinical trial participants were studied and analysed from IRB approved randomized controlled Phase III trials .Number of subjects per trial ranged between 6-74;with duration from 6-72 months. Assessment (31 variables) included demographics, source of recruitment, participation and motivation,consent process,level of satisfaction, overall experience and desire to participate again . Responses were recorded on a scoring system: 0-2 poor, 3-5 good, 6-8 very good, 9-10 excellent. Results: Total of 214 participants were assessed (56 refused to answer; 24 deaths out of 294). 94% were enrolled in clinic visits, 62% participated to explore other treatment options;1.5% to contribute to science/society. Understanding of research was higher in males (n=189) as compared to females (n=25,p< 0.05).Level of satisfaction was higher in educated subjects (n=187) as compared to uneducated(n=27,p <0.05). Excellent score was achieved in research understanding(45%), time given for understanding and voluntary participation (46%), study withdrawal and risk benefit understanding of study participation (51%). 60%were very satisfied with staff ,and 63% would recommend others to participate in clinical trials. Conclusion: Contrary to beliefs participant experience was very satisfactory at a single centre.
| » CPP-37: Trigonelline Ameliorates Diabetes Associated Cognitive Decline, Modulates Oxidative Stress and Acetylcholinesterase Levels in Mice | | |
Amrita Chowdhury, Jyoti Batgire
Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, Maharashtra, India
E-mail: [email protected]
A growing body of evidence suggests a link between diabetes and Alzheimer's disease (AD). Recent literature reveals many similarities between the molecular pathways associated in the pathogenesis of both the diseases. Trigonelline (TRG), a naturally occurring alkaloid, commonly isolated from fenugreek and coffee beans has reported antidiabetic and neuroprotective activity. The present study examines the anti-amnesiac and neuroprotective activity of TRG in diabetes associated cognitive decline (DACD). Streptozotocin (STZ) was injected intraperitoneally to induce diabetes. Morris water maze (MWM) and Y-maze was used to evaluate the spatial and working memory respectively. Lipid peroxidation and markers of oxidative stress such as superoxide dismutase (SOD), reduced glutathione (GSH) were evaluated. Also, cholinergic involvement was assessed by measuring the levels of acetyl cholinesterase (AChE). Chronic treatment with TRG (50 and 100 mg/kg po once daily) and metformin (MFN) (500 mg/ kg po once daily) for 30 dayslowered the blood glucose levels in diabetic mice. The DACD was observed to be ameliorated significantly in both MWM and Y-maze as compared to STZ group. Moreover, oxidative stress was significantly decreased as higher levels of SOD, GSH and lowering of lipid peroxidation was observed in TRG and MFN treated animals as compared to STZ treated mice. Also, significant lowering of AChE was observed in the TRG and MFN treated groups as compared to STZ treated group. In conclusion, the present study demonstrates that TRG supplementation may be beneficial in the treatment of DACD due to its effects on AChE and oxidative stress.
Keywords: Dementia, diabetes, neuroprotective, streptozotocin, trigonelline
| » CPP-38: Mechanistic Study on Cardioprotection Mediated by Irbesartan in Experimental Models of Ischemia/Reperfusion (IR) Injury | | |
Narayanan SP, Tanwar V, Bhatia J, Arya DS
Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
E-mail: [email protected]
Objective: Ischemic heart disease is the leading cause of mortality and morbidity worldwide. The existing therapeutic options for myocardial infarction result in reperfusion injury. The renin angiotensin aldosterone pathway plays an important role in mediating the long term adverse outcomes following myocardial IR injury. Hence in this study we investigated the cardioprotective effect of Irbesartan, an Angiotensin II receptor blocker and the downstream molecular mechanisms involved. Methods: Male wistar albino rats were divided into SHAM, IR control, Irbesartan 15mg/kg + IR, Irbesartan 30mg/kg + IR and Irbesartan 60mg/kg + IR groups and treated with corresponding doses for a period of 15 days, and, on the 15th day, ischemia was produced by ligation of left anterior descending coronary artery for 45 min followed by reperfusion for 60 min. After completion of surgery, the rats were sacrificed, hearts removed and processed for biochemical, morphological, and molecular studies. Results: Irbesartan, dose dependently ameliorated IR injury evidenced by improvement in cardiac function, suppression of oxidative stress and preservation of morphologic alterations. The treated groups had lower levels of cardiac injury markers, upregulation of αβ-crystallin, β catenin and cyclin D1 levels. In addition, it also attenuated apoptosis by reducing the levels of proapoptotic proteins (Bax and Caspase-3), TUNEL positive cells and increasing the level of antiapoptotic proteins (Bcl-2). Conclusions: In conclusion, Irbesartan protected against IR injury by suppressing oxidative stress and apoptosis by upregulation of αβ-crystallin, β catenin and Cyclin D1.
| » Central Nervous System Poster | | |
| » CNSP-1: Socio-demographic Characteristics of Analgesic Misuse among Urban Young Adults of East Sikkim, North East India: A Controlled, Cross-sectional Study | | |
Dass D, Khandelwal B
Department of Pharmacology, Sikkim Manipal Institute of Medical Sciences, Department of Medicine, Sikkim Manipal Institute of Medical Sciences/Central Referral, Gangtok, Sikkim, India
E-mail: [email protected]
Objective: This study was conducted to understand various socio-demographic characteristics such as age, sex, religion, marital status, ethnicity, occupation, income, education, role of migration etc. of analgesic misuse in an urban area of East Sikkim among young adults of 15– 40 years of age of either sex. Methods: A pre-devised questionnaire on socio-demographic characteristic was administered to n=700 subjects after obtaining informed consent. Data was statistically analyzed using Statistical Package for Social Sciences software. Results: Male participants (53.1%) outnumbered female (46.9%). Majority of the participants were literate (84.7%). Most of the participants were occupationally employed (66.8%), Nepali by ethnicity (58.6%), married (64.3%), and Hindu (67.0%) by religion. Significant statistical differences like source of income (χ2 = 18.786, p=0.003), type of accommodation (χ2 = 6.733, p=0.009), average monthly income (χ2 = 11.576, p=0.021), past 30 days incidence of smoking (χ2 = 14.430, p=0.001), pain in the past 30 days (χ2 = 23.282, p<0.001), body mass index (χ2 = 140.224, p<0.001) were reported. Conclusion: Several socio-demographic and lifestyle factors predicted analgesic misuse. Both alcohol consumption and smoking are reported significantly in analgesic misusersas compared to non-misusers.
| » CNSP-2: Evaluation of Anticonvulsant Activity of Leaves of Moringa Oleifera in Albino Rats | | |
Gohain K, Das SM, Lahon A
Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam, India
E-mail: [email protected]
Objective: To study the anti seizure effect of leaves of Moringa Oleifera in albino rats. Materials and Methods: We did the study on 20 Albino rats with ethanol extract of leaves of Moringa Oleifera (EEMO). We divided the rats into four groups. Normal saline was given intraperitoneally in control group. Standard group received phenytoin (25 mg/kg) & diazepam (4mg/kg) intraperitoneally. Than the test groups were given 200mg/kg & 400mg/kg body weight of EEMO intraperitoneally. MES & PTZ tests were carried out on the rats. Convulsion phases were noted down along with the time spent by the animal. The same procedure was repeated with other rats of the control group. The current was passed 30 minutes after intraperitoneal injection of distilled water in control group & phenytoin in standard group. In PTZ test, pentylenetetrazole was injected subcutaneously in all groups & diazepam 4mg/kg was introduced intraperitoneally in the standard group. Results: 400mg/kg body weight of EEMO was seen to be effective as anticonvulsant in this study. Conclusion: This study suggest that the leaves of Moringa Oleifera in high dose is effective as anticonvulsant in rats.
| » CNSP-3: Comparative Study of Analgesic Activity of Ocimum canum and Ougeinia Oojeinensis (Roxb.) Hochr. Stem bark | | |
Hegde Desai V, Vaz L, Mandrekar M, Desai Sawal S, Parab S, Satarker S
Department of Pharmacology, Goa College of Pharmacy, Panaji, Goa, India
E-mail: [email protected]
Objective: The present study was carried out to compare the analgesic activity of Ocimum canum and Ougeinia oojeinensis stem bark. Methods: The ethanolic extract of Ocimum canum and Ougeinia oojeinensis stem bark at doses of 200mg/kg and 400 mg/kg b.w were administered to the rats by oral route for a period of 7 days.The analgesic effect was evaluated by ' hot plate analgesiometer' using pentazocine (5mg/kg) i.p as standard. Ocimum canum extract possesses central analgesic activity,but here we also used the stem bark of Ougeinia oojeinensis to check the extent of difference in activity. Results: With ethanolic extracts of Ocimum canum the basal reaction time was increased significantly (p<0.01) and the percent increase in threshold to pain was also significant as compared to standard. While Administration of Ougeinia oojeinensis for a period of seven days, both the test Groups showed statistical significance for reaction time as compared to control on hot plate analgesiometer. Ocimum canum ethanolic extract (EEOC) 200mg/kg and 400mg/kg shows maximum analgesic activity on day 1 while Ougeinia oojeinensis shows maximum activity on day 7. Conclusion: The ethanolic extract of Ocimum canum possesses better analgesic activity as compared to the ethanolic extract of Ougeinia oojeinensis.
| » CNSP-4: Pharmacological Investigation of Aqueous and Ethanolic Extracts of Stem Bark of Ougenia oojeinensis (Roxb) Hochr on Central Nervous System of Rats | | |
Mandrekar M, Hegde Desai V, Satarker S, Parab S, Vaz L
Department of Pharmacology, Goa College of Pharmacy, Goa University, Panaji, Goa, India
E-mail: [email protected]
Objectives: To evaluate pharmacological effect of Aqueous and Ethanolic Extracts of Stem Bark of Ougenia oojeinensis (Roxb) Hochr On Central Nervous System of Rats. Methods: Female Wistar Albino rats weighing 300-350g were used in the study. Treatment groups were administered with 200mg/kg and 400 mg/kg Ethanolic Extract Of Ougenia oojeinensis (EEOO) and Alcoholic Extract of Ougenia oojeinensis (AEOO) orally using oral feeding syringes. The effects were measured using Elevated Plus Maze, Rotamex and Morris Water Maze.Results: EEOO group at 400mg/kg showed significant increase in % time spent in open arm thus showing anti anxiety effect , EEOO at both dose levels showed decrease in time of fall indicating muscle relaxant effect, while both extracts showed no significant effect on learning and memory. Conclusion: Ougeinia oojeinensis (Roxb.) Hochr. showed a potential anti anxiety, and muscle relaxant property but no significant effects on learning and memory.
| » CNSP-5: Neuroprotective Effect of Withaferin A in rat Model of Lipopolysaccharide Induced Neuroinflammation | | |
Kazi RK, Majumdar AS
Department of Pharmacology, Bombay College of Pharmacy, Mumbai, Maharashtra, India
E-mail: [email protected]
Objective: To evaluate the effect of Withaferin A (WA) in LPS induced neuroinflammation and other associated behavioural and cognitive changes and compare the impact of Withaferin A (WA) and Ibuprofen (IBU) in this paradigm. Methods: Male Sprague-Dawley (SD) rats were pretreated with WA at doses of 5, 25 and 50 mg/kg and Ibuprofen 40 mg/kg body weight once daily by oral gavage for a week prior to LPS administration and continued till the termination of the study. On day 8, rats in all the groups except sham control group were infused unilaterally with ICV-LPS (20 μg/4μl ACSF, at the rate of 0.5μl/min) injection. Rats of all groups were subjected to behavioral and learning and memory tests and subsequently sacrificed on day 18 and their brains were dissected out for biochemical estimations and histopathological examination of the brain tissue. Results: WA attenuated LPS-induced behavioral plus learning and memory deficits which were captured in the paradigms of locomotor activity, morris water maze test (MWM) and novel object recognition test (NORT). In addition, WA improved the brain antioxidant parameters like catalase, superoxide dismutase activities, GSH levels and lowered levels of lipid peroxides and nitrites. There was decrease in acetylcholinesterases (AchE) activity which indicate improvement in cholinergic transmission. The action of ATPases (NA+, K+, Ca2+ and Mg2+) indicating the maintenance of cell membrane potential was also augmented. WA also ameliorated LPS induced neuroinflammation by reducing the levels of the brain inflammatory marker TNF-α and preventing the detrimental morphological changes in brain. Conclusion: The effect of WA was comparable to that of Ibuprofen. These findings opened a new avenue that WA has a promising neuroprotective potential and can be safe and effective alternative to the conventional NSAIDs used for the treatment of the neurodegenerative diseases.
| » CNSP-6: Pharmacological Investigation of Aqueous and Ethanolic Extract of Hedyotis herbacea Linn. On Central Nervous System of Rats | | |
Banaulikar A, Joshi MP, Vaz L
Department of Pharmacology, Goa College of Pharmacy, Panjim, Goa, India
E-mail: [email protected]
Objective: The study was aimed at evaluating the pharmacological effects of Aqueous and Ethanolic extract of Hedyotis herbacea Linn. on rats. Methods: Aqueous extract (AEHH- 4ml) and Ethanolic extract (EEHH- 100mg/kg) were administered orally to Wistar albino rats, weighing 150-200g for a period of 7 days at different time intervals. Diazepam ( 2mg/kg) and Pentazocine(0.5mg/kg) administered intraperitoneally, served as positive controls. Anti-anxiety effect was evaluated using Elevated Plus Maze. Effect on spontaneous locomotor activity was assessed by Opto-varimex and muscle-cordination using Rotarod. The screening for analgesic activity was carried out using Hot Plate Analgesiometer. Results: The Aqueous and Ethanolic extracts showed a significant increase in percentage open arm entries and percentage total time spent in open arms, confirming anti-anxiety effect.The extracts showed a prominent decrease in distance travelled, ambulatory time and an increase in the resting time with autotrack. However,with ethanolic extract the fall time from the rota rod was decreased as compared with the aqueous extract. The aqueous extract showed better reaction time on the hot plate analgesiometer than the ethanolic extract for the analgesic activity. Conclusion: The Aqueous and Ethanolic extract of Hedyotis herbacea Linn showed potential anti-anxiety activity, analgesic activity but no significant muscle co-ordination and locomotor activity.
| » CNSP-7: Glutamate Receptors and Inflammation: Potential Targets in DID | | |
Dethe PV, Chincholkar AB
Satara College of Pharmacy, Satara, Maharashtra, India
E-mail: [email protected]
Dissociative identity disorder (DID), a cryptic neurological disorder affecting 0.1 to 2 % of population worldwide and 0.01 % in India. In DID, the person switches from one identity to another without the influence of any identity over each other. According to diagnostic and statistical manual of mental disorders (DSM V) DID is characterized by amnesia, alterations in cognition, memory and perception. The data was assembled through search on PubMed and sciencedirect using the keywords like DID, trauma, neuroplasticity and inflammation. Articles published up-to December 2017 were studied. Advanced neuroimaging studies revealed that there is decrease in size of hippocampus and amygdala in DID. The neurotransmitters, serotonin and glutamate are released during ischemia in bilateral OFC which play a vital role in pathophysiology of DID. Glutamate activates NMDA and AMPA receptors causing neurotoxicity and loss of memory by disturbing the hippocampus-prefrontal cortex circuits. In addition, TNF-alpha is released during trauma leads to apoptosis via activation of Caspase-8. In contrast, activation of NF-kB through TNF-alpha mediated PI-3/AKT pathway protect neurons by expressing Bcl2 genes. Along with neurotoxicity, glutamate in combination with Neutrophins (BDNF and NGF) is involved in dysregulating neuroplasticity which plays a major role in dissociation by developing new neural circuits. Activation of PI-3/AKT and inhibition of glutamate receptors and neutrophins may bring a relief from DID. Researchers have successfully carried out preclinical studies of antagonists of NMDA receptors resulting in attenuation of neuronal death and impaired cognitive processes. Also, the effect of antagonist targeting BDNF and NGF has been studied with positive results. Hence, targeting glutamate receptors and inflammation may provide alternative approach to treat DID.
| » CNSP-8: Comparative Study of Phytochemical Constituents and Pharmacological Activity of Leaf Extracts of Bombax ceiba and Bombax insigne | | |
Samant PB, Godinho MHS
Department of Pharmacology, Goa College of Pharmacy, Panaji, Goa, India
E-mail: [email protected]
Objective: The aim of the present study was to evaluate and compare the phytochemical constituents and the pharmacological activity of ethanolic extracts of dried leaves of Bombax ceiba and Bombax insigne. Methods: Animal models such as elevated plus maze and hot plate analgesiometer were used for the purpose. The rats were divided into 7 groups:- Group I (2% Tween 80 as control), Group II (Diazepam 2mg/kg as standard), Group III (Pentazocine 5mg/kg as standard), Group IV (Ethanolic extract of dried leaves of Bombax ceiba 200 mg/kg), Group V (Ethanolic extract of dried leaves of Bombax ceiba 400 mg/kg), Group VI (Ethanolic extract of Bombax insigne 200 mg/kg) and Group VII (Ethanolic extract of Bombax insigne 400 mg/kg). Results: On elevated plus maze model, rats administered with ethanolic extract of Bombax ceiba at a dose of 400 mg/kg showed better anti-anxiety activity. On hot plate analgesiometer, rats administered with ethanolic extract of Bombax ceiba at a dose of 400 mg/kg showed better analgesic activity. During phytochemical analysis, mangiferin content and total flavonoid content was found to be higher in the ethanolic extract of Bombax insigne as compared to ethanolic extract of Bombax ceiba whereas, ethanolic extract of Bombax ceiba showed higher amount of total phenolic content and total tannin content as compared to ethanolic extract of Bombax insigne. Conclusion: The anti-anxiety activity and analgesic activity demonstrated by ethanolic extract of Bombax ceiba could be due to presence of higher amount of total phenolic compounds and certain phytoconstituents.
| » CNSP-9: “Study of Essential Oil as Protective agent for Neurological disorders” | | |
Jyoti Vishwakarma, Poonam Choudhary, Priti Patel
Department of Pharmacology, Dr. L.H. Hiranandani College of Pharmacy, Ulhasnagar, Maharashtra, India
Objective: The objective of this study was to evaluate the neuroprotective efficacy of essential oil of laurus nobilis linn. With Donepezil in scopolamine induced amnesia in mice. Materials and Methods: 6 groups of male swiss albino mice weighing (18-25gm) (n=6) were used. The normal group received normal saline for the duration of 7 successive days. Amnesia was induced in the rest of the groups by administration of scopolamine intraperitoneally (0.2mg/kg per day for 7 days). In addition standard control group received donepezil (4mg/kg/day), EOI, EOII group received essential oil of laurus nobilis orally at the dose of (4mg/kg, 8mg/kg) respectively, whereas EOIHAL group was exposed to aroma of essential oil of laurus nobilis linn. in enclosed chamber for 20 min per day for 7 days. Cognitive performance was assessed by elevated plus maze and pole climbing test. Acetylcholine esterase and biochemical like lipid peroxidase and glutathione level of mice brain were estimated by statistics analysis of variances followed by dunett's test P≥0.05 was considered statistically significant. Results: Treatment with donepezil and essential oil of laurus nobilis by oral as well as by inhalation route decrease in transfer latency and increase in CAR in respectively cognitive decrease in ACHE levels was also observed biochemical maker such as GHS and decrease in lipid peroxidase was observed as compared to scopolamine treated controlled group. Conclusion: The study demonstrate that antiamnesic potential of essential oil of laurus nobilis linn. by oral as well as inhalation route cognitive memory due to effect of essential oil of laurus nobils linn. by decrease in ACHE level and maintaining homeostatiss action in scopolamine dementic mice.
Keywords: ACHE, amnesia, donepezil, scopolamine
| » CNSP-10: Pharmacological Evaluation of Benincasa hispida on Chronic Foot Shock Induced Stress in Mice | | |
Wankhade AM, Dhuldhar R, Vyas JV, Tapar KK
Vidyabharati College of Pharmacy, Amravati, Maharashtra, India
E-mail: [email protected]
Introduction: Stress can be defined as a brain-body reaction towards stimuli arising from the environment or from internal cues that are interpreted as a disruption of homeostasis. A number of reports indicated that treatment with herbal plant extracts could lead to a significant reduction in stress. The aim of this study was to evaluate the antistress activity through Inescapable electric chronic foot shock model in mice and to assess the effect of extract on stress induced behavioral changes in animals and to determine the efficiency of Benincasa hispida extract on Freezing behavior ,Motor activity and Elevated plus maze to assess anxiety. Methods: In this study, mice were divided into five groups with five animals each. The first group received ip dose of the vehicle along with chronic stress (2ml/kg). The second group received diazepam 1mg/kg ip along with foot shock. Third, Forth, and fifth groups received oral dose of 100, 200, and 400 mg /kg of fruit extract of Benincasa hispida along with foot shock. Inescapable electric Foot-shocks (intensity 0.8mA, interval: 10sec, duration: 10sec) were delivered through a grid floor once daily for 21 days. Then, plus maze for anxiety, Freezing behavior and motor activity were assessed for antistress effect. Results: The results showed the Benincasa hispida extract (200 and 400mg/kg) was found to have an antistress effect on locomotor activity, elevated plus maze activity and freezing behavior. The dose of Benincasa hispida extract (200 and 400mg/kg), increased entries into open arm and the time spend in open arm in the elevated plus maze test indicate that extract reduced the stress level and it significantly reduced the spontaneous motor activity and decreases the freezing behavior. Conclusion: The results suggest that the ethanolic extract of Benincasa hispida has potential antistress effect that can be explored for therapeutic advantage as an alternative treatment in medical conditions.
| » CNSP-11: Antineuropathic Effect of Apigenin in Chronic Construction Injury of Sciatic Nerve in Rats | | |
Chaudhari Sayli Y1, Talla Sandhya1, Mahajan Umesh B1, Patil Chandragouda R1, Goyal Sameer N1,2
1Department of Pharmacology, R. C. Patel Institute of Pharmaceutical Education and Research, 2SVKM's, Institute of Pharmacy, Dhule, Maharashtra, India
E-mail: [email protected], [email protected]
Introduction: Apigenin is recognized as a bioactive flavonoid shown to possess anti-inflammatory, antioxidant property and reduced cytokines level by inhibiting the important immune cells, inflammatory cells and its chemical mediators. Objective:To evaluate antineuropathic effect of Apigenin in chronic constriction injury of sciatic nerve in rats. Methodology: Neuropathic pain was induced in albino Wistar rats by 4 loose ligature knots, 1 mm apart, on the unilateral sciatic nerve. Total five study groups as normal, sham operated, CCI-control, apigenin treated and gabapentin treated group were assessed. Nociceptive thresholds were assessed on 3rd, 7th, 11th and 14th. Cytokines level was assessed on day 7th, MNCV on day 14th and then the estimation of total protein, oxidative stress parameters such as LPO, SOD, GSH and catalase. Histological evaluation was done by taking the L.S. of sciatic nerve on day 14th. Results: CCI-induced rats cause to produce hyperalgesia, oxidative stress and cytokines level (IL-6, IL-1β and TNF-α) as compared to normal rats, whereas apigenin treated rats improves paw withdrawal latency in cold and warm allodynia, increased paw withdrawal threshold in mechanical allodynia test, increased the motor nerve conduction velocity and down regulated the level of IL-6, IL-1β and TNF-α. It also decreased levels of MDA and increased levels of SOD, GSH and Catalase. In histopathology studies apigenin was found protective. Conclusion: The present study was designed to evaluate the anti-neuropathic effect of apigenin in the chronic constriction injury of the sciatic nerve (CCI model) in rats.
| » CNSP-12: Gene Therapy and Alzheimer's: Recent Developments | | |
Bandyopadhyay P, Thaggikuppe P
Birla Institute of Technology, Ranchi, Jharkhand, India
E-mail: [email protected]
Objective: Gene Therapy is a therapeutic approach in which genes are incorporated in order to cure a disease. Alzheimer's disease is a chronic neurodegenerative disorder which slowly reduces memory power finally leading to total loss of it. It is the major cause of dementia.
Gene therapy is also being experimentally used as a cure of Alzheimer's. Methods: One of the earliest approaches of gene therapy on Alzheimer's treatment was done by the delivery of NGF (Nerve Growth Factor) to the cholinergic systems. The widely known and most successful attempt of gene therapy approaches towards Alzheimer's disease was conducted by scientists of Imperial College London, U.K. who have modified lentivirus to deliver the therapeutic gene, PGC-1 alpha. Results: On insertion of the therapeutic gene, they showed few amyloid plaques, better memory and no further loss of unaffected brain cells. They even had a lower number of glial cells which are responsible for the release of toxic inflammatory substances causing additional damage to cells. Conclusion: Currently there is no cure for the progression of the disease, only the symptomatic relief can be made by the drug therapy. The protection or further progression of brain cell death is achieved by gene therapy methods in animal models. These methods are also being used in human beings under various clinical trial phases.
| » CNSP-13: Chronic Unpredictable Mild Stress Induced Alterations in Brain Insulin Resistance in mice: Effects of Duloxetine, Pioglitazone and Co-enzyme Q10 | | |
Harish KR, Tousif AH, Chethan N, Bipul Ray, Abid Bhat, Saravana Babu Chidambaram, Meena Kishore Sakharkar1
Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore, Karnataka, India, 1College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada
E-mail: [email protected], [email protected]
Objective: The current investigation was undertaken to study the effects of duloxetine, serotonin - norepinephrine reuptake inhibitor, pioglitazone, peroxisome proliferator-activated receptor γ (PPARγ) agonist/ mitochondrial biogenesis inducer and co-enzyme Q10, antioxidant, and their combinations thereof to combat chronic unpredictable mild stress (CUMS) induced alterations in brain insulin resistance and depressive behaviour in a mouse model. Methods: Depressive behaviour in mice was induced by applying CUMS for a period of 9 weeks. On day 64, forced swim and tail suspension tests were performed to score depression. On day 65, stress markers - corticotropin releasing factor 1 receptor (CRF1R), insulin resistance markers - IRS1 and IRS2, and mitochondrial biogenesis markers such as PGC1a, NRF1 & 2 and TFAM protein expressions were analysed by western blotting. Serum cortisol was measured by the ELISA assay and superoxide dismutase activity (SOD) by spectrophotometry. Results: Duloxetine reversed depressive behaviours with concomitant down-regulation of CRF1R. However, it failed to up-regulate PGC1a, NRF1&2 and TFAM and SOD activity. Pioglitazone partially reversed depression and significantly up-regulated PGC1a, NRF1&2 and TFAM. Co-enzyme Q10 failed to produce either anti-depressant action or insulin resistance. Amongst the tested combinations, duloxetine and pioglitazone produced synergistic anti-depressive effects and prevented insulin resistance. Also, this combination effectively improved mitochondrial biogenesis and SOD activity. Conclusion: The combination of duloxetine and pioglitazone produced synergistic anti-depressant effects and ameliorated insulin resistance and mitochondrial functions. This combination seems to be an interesting regimen for further investigations.
| » CNSP-14: Effect of 3, 4, 5-trimethoxycinnamic acid (TMCA) on β-amyloid induced Alzheimer's disease in wistar rats | | |
Dhawale K, Patil A, Arulmozhi S, Sathiyanarayanan L, Mahadik KR
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
E-mail: [email protected]
Objective: The investigation was designed to evaluate effect of TMCA on β-amyloid induced Alzheimer's disease. Methods: The animals were injected in intracerebroventricular region with 10 μg of β-Amyloid Peptide. After14 days recovery, the animals were randomly divided into 5 groups: Alzheimer's control, standard donepezil, test treated with TMCA(10, 50 and 100 mg/Kg) orally once daily for 21 days. Two comparative groups normal control and sham operated were also treated with vehicle for 21 days. The behavior of animal in Moris water maze was evaluated for spatial memory.The brain oxidative stress, BDNF, GABA and acetylcholinesterase activities were measured. Results: Treatment with TMCA (50 and 100 mg/kg) significantly decreased the escape latency time. Level of BDNF was restored after treatment with TMCA (10 and 50 mg/kg) in β-amyloid induced Alzheimer's disease. Increased brain NO level in Alzheimer's rats was significantly decreased by treatment of TMCA (50 and 100 mg/kg) as compared to Alzheimer control groups. Level of GABA was also restored after treatment with TMCA (10, 50 and 100 mg/kg. The acetylcholinesterase activity found to be decreased in TMCA (50 and 100 mg/kg) treated rats. Conclusion: These findings orchestrate the anti-oxidative and free radical scavenging of TMCA.Neuroprotective effect of TMCA could be via modulation of oxidative stress, brain-derived neurotrophicfactor (BDNF), decreased acetylcholinesterase activity and increased GABA level
| » CNSP-15: Effect of Lupeol on β-amyloid Induced Alzheimer's disease in Wistar Rats | | |
Bhosale S, Das S, Rojatkar SR, Arulmozhi S, Sathiyanarayanan L, Mahadik KR
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
E-mail: [email protected]
Objective: The study was designed to evaluate the effect of lupeol on β-amyloid induced Alzheimer's disease. Methods: The animals were injected in intracerebroventricular region with 10 μg of β-Amyloid Peptide. After 14 days of recovery, the animals were randomly divided into 5 groups: Alzheimer's control, standard donepezil, and test treated with lupeol (1, 5 and 10 mg/Kg) orally once daily for 21 days. Two comparative groups: normal control and sham operated were also treated with the vehicle for 21 days. The behavior of the animal in Morris water maze was evaluated for the spatial memory. The brain oxidative stress, BDNF, GABA and acetylcholinesterase levels were measured. Results: Treatment with lupeol (5 and 10 mg/kg) significantly decreased the escape latency time in Morris water maze. Level of BDNF was restored after treatment with lupeol (5 and 10 mg/kg) in β-amyloid induced Alzheimer's disease. Increased brain NO level in Alzheimer's rats was significantly decreased by treatment of lupeol (5 and 10 mg/kg) as compared to Alzheimer control groups. The brain acetylcholinesterase activity found to be decreased in lupeol (5 and 10 mg/kg) treated rats. Conclusion: The above findings confirmed the anti-oxidative and free radical scavenging of lupeol. Neuroprotective effect of lupeol could be via modulation of oxidative stress, brain-derived neurotrophicfactor (BDNF), decreased acetylcholinesterase activity and increased brain GABA level.
| » CNSP-16: Evaluation of Effect of Rhodanine on STZ Induced Alzheimer's disease in Wistar Rats | | |
Ahuja S, Arulmozhi S, Sathiyanarayanan L, Zambare GN, Mahadik KR
Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
E-mail: [email protected]
Objective: To evaluate the effect of Rhodanine on STZ induced Alzheimer's disease by tau hyperphosphorylation inhibition. Methods: Wistar rats of 220g to 250g each induced with Alzheimer's using streptozocin, injected intracerebroventricularly by the help of stereotaxy apparatus. Animals were divided into 7 groups with 7 animals each, which were subjected to Morris water maze to check their status of disease in the animal, the escape latency was calculated using video tracking device and two way ANOVA. The animals were sacrificed on the last day of the project and their brains were isolated for histopathology and antioxidant parameters. Results: There was a decrease in the level of MDA and NO whereas increase in the level of SOD, GSH and GABA upon treatment with rhodanine. There was also a decrease in the escape latency of the animals in rhodanine treated groups, which indicate the improvement in the spatial memory because of the treatment. Conclusion: Thus the rhodanine is effective in improving the memory in STZ induced Alzheimer's which may be due to the decrease in the free radicals, NO and MDA which offer a neuroprotection. This is further confirmed by the increase in the brain SOD and GSH.
| » CNSP-17: Evaluation of Ferulic Acid on Chemotherapeutic Drug Induced Neuropathy in Laboratory Animals | | |
Warokar KV, Patil VR1, Aswar MK
Department of Pharmacology, Sinhgad Institute of Pharmacy, Pune, 1College of Pharmacy, Jalgaon, Maharashtra, India
E-mail: [email protected]
Objective: The objective of present study is to evaluate the effect of ferulic acid (FA) on chemotherapeutic drug (Cisplatin and Paclitaxel) induced neuropathy in laboratory animals.To study effect of ferulic acid on various biochemical markers involved in neuropathy. Methods: For cisplatin induced neuropathy in laboratory animals, animals were randomly divided into six groups (n=6). The animals in normal group received only vehicle (1ml/kg p.o.) and in control, standard [Pregabalin (PREG 10mg/kg p.o.)] and test [FA (10, 20, 30 mg/kg)] group received cisplatin (2 mg/kg i.p.) twice a week for 5 weeks. For paclitaxel induced neuropathy in laboratory animals, animals were randomly divided into six groups (n=6). The animals in normal group received only vehicle (1ml/kg p.o.) and in control, standard [Pregabalin (PREG 10mg/kg p.o.)] and test [FA (10, 20, 30mg/kg)] group received paclitaxel (1mg/kg i.p.) on alternate day for 21 days. After 5 weeks for cisplatin and after 3 weeks of paclitaxel |
